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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN SAVVIO 3ML (GRAPHITE) FOR TREATMENT PURPOSES

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ELI LILLY AND COMPANY HUMAPEN SAVVIO 3ML (GRAPHITE) FOR TREATMENT PURPOSES Back to Search Results
Model Number MS9698
Device Problems Air Leak (1008); Insufficient Flow or Under Infusion (2182)
Patient Problems Abdominal Pain (1685); Hyperglycemia (1905)
Event Date 07/09/2016
Event Type  Injury  
Manufacturer Narrative
No further follow up is planned. Evaluation summary the patient experienced hyperglycaemia while using a humapen savvio (lot 1403v07). There was no product complaint for the device and it was not returned for investigation there was evidence of improper use of the device. It was reported the patient left the needle attached to the pen for one hour after injection and used a cartridge of insulin that was full of bubbles. There was no product complaint relative to pen function, however, the use errors may be relevant to the event of hyperglycaemia. The device user manual indicates to 'prevent air' from entering the cartridge, do not store the pen with the needle attached', and to 'remove the needle after every use'. In addition, users are instructed to inspect the cartridge prior to each use for appearance, to prime the pen prior to each use, pointing the pen upwards and gently tapping on the cartridge to remove air bubbles.
 
Event Description
(b)(4). This spontaneous case, reported by a consumer who contacted the company to report an adverse event and a product complaint, concerns an (b)(6) male patient. The medical history of patient included diabetes since approximately (b)(6) 2016 and the use of human insulin nph and human insulin regular via syringe for unknown indications. The concomitant medication included insulin glargine for unknown indication. The patient received insulin lispro (humalog) cartridge via reusable pen, 1 iu for every 50 over 200 of blood glucose and 1 iu for each 35 grams in carbohydrates counting, 5 times a day (according to carbohydrates counting), subcutaneously, for unknown indication, beginning on (b)(6) 2016. On (b)(6) 2016, five days after beginning insulin lispro therapy via humapen savvio graphite (lot number 1403v07), the patient started to experience hyperglycemia, the blood glucose of patient reached 300 (unit and normal range was not provided). After the glycemic event, it was noted that there were bubbles inside the cartridge of insulin lispro, but it was unknown when they appeared. According to reporter the cartridge was full of bubbles and, due to that, the reporter believed that insulin was being lost resulting in no effect. Conflicting information was provided by initial reporter on 15jul2016 as the lack of drug effect was related to the problem of humapen savvio graphite ((b)(4)) and the reporter was afraid of air entrance (as reported). As corrective treatment the treating physician increased the dose of insulin glargine from 22 iu to 24 iu each morning and increased the dosage of insulin lispro too. From the 9:00 p. M. Of (b)(6) 2016 until the 3:00 a. M. Of (b)(6) 2016 the patient received 6 iu of insulin lispro, however, the blood glucose did not decrease. Also, on (b)(6) 2016, it was reported that insulin lispro was applied twice, however, the blood glucose reached 330 and it took too long to decrease. On (b)(6) 2016 the patient was experiencing abdominal pain due to hyperglycemia and he was taken to emergency room when he received saline solution for three hours as corrective treatment but his glycemia did not decrease. The patient was not hospitalized and he was released by physician to go home in order to avoid an infection because he was diabetic (as reported) and physician instructed to continue the dose adjustment with carbohydrates counting. The event of hyperglycemia was considered serious due to medically significant reason by the company. The patient did not recover from hyperglycemia and the outcome for possible underdose was not provided. It was reported that the operator of device let the needle attached to the pen during one hour after application. Information regarding exams was not provided. The reporting consumer believed injection screw of humapen savvio graphite was not working ((b)(4)). On (b)(6) 2016 the reporter manipulated the pen and it was working but the reporter no longer relied on it. The reporting consumer stated the pen was releasing insulin but was afraid it was not releasing the selected units because the liquid of insulin lispro cartridge was not decreasing as observed for the insulin glargine. The reporting consumer would contact company again if the event of hyperglycemia did not resolve. The insulin lispro therapy was continued. The mother of patient operated the device and she was trained by a physician. This device model and the reported device were used for unknown period of time. The device continued to be used and its return was not expected. The reporting consumer did not relate the hyperglycemia to insulin lispro therapy but considered this event related to the presence of bubbles inside the cartridge and to the possible underdose. Also, the reporting consumer related the possible underdose to the presence of bubbles inside the cartridge of insulin lispro and to problem of humapen savvio graphite. No other assessment of relatedness was provided. Update 13jul2016: additional information received from initial reporter on 12jul2016 was processed within the initial report. Update 15jul2016: upon review, this case was opened to update the medwatch fields for regulatory reporting. Update 15jul2016: additional information received on 15jul2016 from the global product complaint database added the device specific safety summary; updated the medwatch and european and canadian required device reporting elements; and updated the narrative. Update 18jul2016: additional information was received on 15jul2016 from initial reporter via call center. Updated description as reported of underdose event to patient possibly did not receive insulin lispro due to bubbles in the cartridge and problem of pen; added patient received saline solution as corrective treatment for hyperglycemia and he was not hospitalized; added complaint description regarding suspect device humapen savvio graphite; added mother of patient operated the device; added reporting consumer also considered the event of possible underdose related to the humapen savvio graphite. Corresponding fields and narrative updated accordingly.
 
Manufacturer Narrative
Narrative field - new, updated and corrected information is referenced within the update statements in describe event or problem. Please refer to update statement dated 19aug2016 in the field. No further follow up is planned. This report is associated with 1819470-2011-00225, since there is more than one device implicated. Evaluation summary the mother of a male patient reported that her son's humapen savvio device was not releasing insulin. The patient experienced hyperglycemia. The device was not returned to the manufacturer for investigation (batch (b)(4), manufactured march 2014). Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction. Malfunction unknown. All humapen savvio devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality and dose accuracy with high probability. Troubleshooting was performed by the reporter with guidance of a trained professional, attaching a new needle to the device. The insulin was then released normally. There is no evidence of improper use.
 
Event Description
(b)(4). This spontaneous case, reported by a consumer who took part of patient support program (psp) and contacted the company to report an adverse event and a product complaint, concerns an (b)(6) male patient. Medical history: diabetes since approximately mar2016, human insulin (rdna origin) nph (humulin n) and human insulin (rdna origin) regular (humulin r) from 09mar2016 to approximately 09jun2016, attention deficit disorder and the patient was born with just one kidney. Concomitant medications: insulin glargine for unknown indication and an unspecified medication for anxiety because the patient presented attention deficit disorder. The patient started the therapy with insulin lispro (humalog) cartridge via reusable pen, 1 iu for every 50 over 200 of blood glucose and 1 iu for each 35 grams in carbohydrates counting, 5 times a day (according to carbohydrates counting), subcutaneously, for unknown indication, starting on (b)(6) 2016. During an unspecified time of the beginning of insulin lispro therapy, as corrective treatment while the patient was adapting to the medication, human insulin regular was applied sometimes, according to the treating physician orientation. On (b)(6) 2016, five days after beginning insulin lispro therapy via humapen savvio graphite (lot number 1403v07), the patient started to experience hyperglycemia, the blood glucose of patient reached 300 (units and normal ranges were not provided). After the glycemic event, it was noted that there were bubbles inside the cartridge of insulin lispro, but it was unknown when they appeared. According to reporter the cartridge was full of bubbles and, due to that, the reporter believed that insulin was being lost resulting in no effect. Conflicting information was provided by initial reporter on 15jul2016 as the lack of drug effect was related to the problem of humapen savvio graphite ((b)(4)) and the reporter was afraid of air entrance (as reported). As corrective treatment the treating physician increased the dose of insulin glargine from 22 iu to 24 iu each morning and increased the dosage of insulin lispro too, according to carbohydrates counting, which was around 15 or 20 iu daily. From the 9:00 p. M. Of (b)(6) 2016 until the 3:00 a. M. Of (b)(6) 2016 the patient received 6 iu of insulin lispro, however, the blood glucose did not decrease. Also, on (b)(6) 2016, it was reported that insulin lispro was applied twice, however, the blood glucose reached 330 and it took too long to decrease. On (b)(6) 2016 the patient was experiencing abdominal pain due to hyperglycemia and he was taken to emergency room when he received saline solution for three hours as corrective treatment but his glycemia did not decrease. The patient was not hospitalized and he was released by physician to go home in order to avoid an infection because he was diabetic (as reported) and physician instructed to continue the dose adjustment with carbohydrates counting. This event of hyperglycemia was considered serious due to medically significant reason by the company. Additionally, it was informed that since an unknown date, when the glycemia of the patient was high, he could not control the urination, he presents a lot of abdominal pain and becomes a bit confused (reported as disorientated), as symptoms. The patient did not recover from hyperglycemia and the outcome for possible underdose was not provided. It was reported that the operator of device let the needle attached to the pen during one hour after application and the needle remained into the skin of the patient during 10 seconds after the application. The reporting consumer believed injection screw of humapen savvio graphite was not working (product complaint 3718360) since an unknown date. On (b)(6) 2016 the reporter manipulated the pen and it was working but the reporter no longer relied on it. The reporting consumer stated the pen was releasing insulin but was afraid it was not releasing the selected units because the liquid of insulin lispro cartridge was not decreasing as observed for the insulin glargine. The reporting consumer would contact company again if the event of hyperglycemia did not resolve. Since (b)(6) 2016 the patient was experiencing hyperglycemia and was a bit nervous, as (b)(6) 2016 was his first day of school after the holidays. On (b)(6) 2016 the patient experienced hyperglycemia during the whole day. In the afternoon the patient presented a glycemia of 283. Due to this, the patient could not control the urination. On the same day, the insulin was applied, the patient ate the afternoon snack, and after this his glycemia was 311. After 07:00 p. M. The glycemia started decreasing. Two hours after the last measure, it was 205, at 09:00 p. M. It was 167 and at 10:40 p. M. It was 110. The patient ate a snack (porridge and oats) before going to bed, which sustained him the whole night. This episode of hyperglycemia was considered medically significant since according to the reporter it was serious. When the reporter verified the pen, it was realized that it was not working appropriately. The reporter had to move the screw (pen cursor) until it touched in the insulin lispro vial (lot number: c459940a). As corrective treatment for the hyperglycemia, on (b)(6) 2016 the reporter measure the glycemia of the patient each two hours and corrected it the whole day. The corrective treatment for the nervousness was not provided. The patient recovered from these events on (b)(6) 2016. On unknown dates the patient underwent all the lab tests required by the treating physician, including the check-up of glycosylated hemoglobin (the units, normal ranges and values were not provided). Humapen savvio graphite (lot number 1403v07) was associated with (b)(4). The insulin lispro therapy was continued. The mother of patient operated the device and she was trained by a physician. This device model and the reported device were used since 06jul2016. The device continued to be used and its return was not expected. The initial reporting consumer did not relate the first episode of hyperglycemia to insulin lispro therapy but considered this event related to the presence of bubbles inside the cartridge and to the possible underdose. Also, the possible underdose was considered related to the presence of bubbles inside the cartridge of insulin lispro and to the problem of humapen savvio graphite. The initial reporting consumer did not relate the second episode of hyperglycemia and the nervousness with insulin lispro therapy. The second episode of hyperglycemia was considered related with the problem of humapen savvio graphite. No other assessment of relatedness was provided. This case is cross-referenced with the following cases (b)(4) (same patient). Update 13jul2016: additional information received from initial reporter on 12jul2016 was processed within the initial report. Update 15jul2016: upon review, this case was opened to update the medwatch fields for regulatory reporting. Update 15jul2016: additional information received on 15jul2016 from the global product complaint database added the device specific safety summary; updated the medwatch and european and canadian required device reporting elements; and updated the narrative. Update 18jul2016: additional information was received on 15jul2016 from initial reporter via call center. Updated description as reported of underdose event to patient possibly did not receive insulin lispro due to bubbles in the cartridge and problem of pen; added patient received saline solution as corrective treatment for hyperglycemia and he was not hospitalized; added complaint description regarding suspect device humapen savvio graphite; added mother of patient operated the device; added reporting consumer also considered the event of possible underdose related to the humapen savvio graphite. Corresponding fields and narrative updated accordingly. Update 04aug2016: additional information received on 02aug2016 from the initial reporting consumer. Updated the height of the patient. Added date of the therapies with the historical drugs human insulin nph and human insulin regular. Added attention deficit disorder and the patient was born with just one kidney as medical histories. Added unspecified medication for anxiety as concomitant medication. Added information regarding adaptation of insulin lispro therapy. Added dose and frequency of insulin lispro therapy. Added uncontrolled urination, abdominal pain and confusion as symptoms of high glycemia. Added information regarding improper use of humapen savvio graphite. Added hyperglycemia as serious adverse event. Added nervousness as non-serious adverse event. Added uncontrolled urination as symptom of the hyperglycemia. Added serious criteria for the episode of hyperglycemia. Added lab tests. Added start date of the device model and the reported device. Added information of pc. Added cross-referenced case. Updated narrative and fields appropriately. Edit 08aug2016: upon internal review, it was added an additional reporter of patient support program. Edit 18aug2016: upon internal review on 18aug2016, it was added a new suspect device. Updated narrative and fields appropriately. Update 18aug2016: upon review, this case was opened to update the medwatch fields for regulatory reporting. Update 19aug2016: additional information received on 19aug2016 from the global product complaint database added an updated device specific safety summary for the device associated with (b)(4); updated the medwatch fields; and updated the narrative. Update 31aug2016. Additional information received 31aug2016 from the product complaint safety database. To the device tab added the device specific safety summary (dsss) for device associated with (b)(4), updated the device medwatch information, and the narrative was updated accordingly.
 
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Brand NameHUMAPEN SAVVIO 3ML (GRAPHITE)
Type of DeviceFOR TREATMENT PURPOSES
Manufacturer (Section D)
ELI LILLY AND COMPANY
lilly corporate center
indianapolis IN 46285
Manufacturer (Section G)
ELI LILLY AND COMPANY
lilly corporate center
indianapolis IN 46285
Manufacturer Contact
caroline rosewell
lilly corporate center
indianapolis, IN 46285
3172764376
MDR Report Key5811814
MDR Text Key50095162
Report Number1819470-2016-00186
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K160668
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup
Report Date 07/12/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMS9698
Device Lot Number1403V07
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/19/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/31/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/21/2016 Patient Sequence Number: 1
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