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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN ERGO II FOR TREATMENT PURPOSES

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ELI LILLY AND COMPANY HUMAPEN ERGO II FOR TREATMENT PURPOSES Back to Search Results
Model Number MS9557
Device Problem Break (1069)
Patient Problems Hyperglycemia (1905); Hypoglycemia (1912); Sweating (2444)
Event Type  Injury  
Manufacturer Narrative
If device is returned, evaluation will be performed to determine if a malfunction has occurred. This is an initial report. A follow-up report will be submitted when the final evaluation is completed.
 
Event Description
(b)(4). This solicited case, reported by a consumer via a patient support program (psp), concerned a (b)(6) male patient. Medical history was not provided. Concomitant medications included an unspecified medication reported as kaboping. The patient received insulin lispro protamine suspension 50%/insulin lispro 50% (rdna origin) (humalog mix50) injections from a cartridge via a reusable pen (humapen ergo ii), 14 unspecified units in the morning, 6 unspecified units at noon and 12 unspecified units in the evening subcutaneously for the treatment of diabetes, beginning on (b)(6) 2014. Sometime in 2014, he got the eli-lilly injection pen gave by (b)(6). On an unspecified date, after he started using insulin lispro protamine suspension 50%/insulin lispro 50%, he had the symptom of high blood sugar (no values, reference values or details were provided). Physician let him adjusted dosage to 16 unspecified units in the morning, 6 to 7 unspecified units at noon, and 14 unspecified units in the evening. Then, physician changed dosage to 18 unspecified units in the morning, 7 unspecified units at noon, and 16 unspecified units in the evening. The last change of dosage was 20 unspecified units in the morning, 8 unspecified units at noon, and 18 unspecified units in the evening. On an unknown date, he was hospitalized twice to adjust blood sugar. No more details regarding admission and discharge dates as well as treatment and laboratory tests done while hospitalized were provided. On another unspecified date, if he ate less in the morning, he would have hypoglycemia before noon with shivered convulsively, at the moment nigrescent and sweating. These symptoms were relieved after eating some food. On (b)(6) 2016 was the last time with hypoglycemia. At that time, the symptom relieved after eating some fruit drops. Also, the front of injection pen was broken down and could not install syringe needle. On that same date, he changed a new injection pen in (b)(6). Information regarding additional corrective treatment and outcome of the remaining events was not provided. Insulin lispro protamine suspension 50%/insulin lispro 50% treatment was continued. The operator of the device and his or her training status was not provided. The device model duration of use was since 2014. The reported device duration of use was not provided. If device would be returned, an evaluation would be performed to determine if a malfunction has occurred. The consumer reporter did not know if the events were related the insulin lispro protamine suspension 50%/insulin lispro 50% therapy but did not provide a relatedness assessment between them and device. Edit 23may2016. Case was opened to enter medwatch device fields for device mailing. No new information. Edit 23-may-2016: upon internal review, the case was reopened in order to adding missing product complaint information to the narrative. No additional information was added to the case.
 
Manufacturer Narrative
No further follow up is planned evaluation summary: a male patient reported that the front of his humapen ergo ii device was broken down and he could not install the needle. He experienced abnormal blood glucose levels. The device was not returned to the manufacturer for investigation (batch unknown). Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction. Malfunction unknown. There is no evidence of improper use or storage.
 
Event Description
(b)(4). This solicited case, reported by a consumer via a patient support program (psp), concerned a (b)(6) male patient. Medical history was not provided. Concomitant medications included an unspecified medication reported as kaboping. The patient received insulin lispro protamine suspension 50%/insulin lispro 50% (rdna origin) (humalog mix50) injections from a cartridge via a reusable pen (humapen ergo ii), 14 unspecified units in the morning, 6 unspecified units at noon and 12 unspecified units in the evening subcutaneously for the treatment of diabetes, beginning on (b)(6) 2014. Sometime in 2014, he got the eli-lilly injection pen gave by (b)(6). On an unspecified date, after he started using insulin lispro protamine suspension 50%/insulin lispro 50%, he had the symptom of high blood sugar (no values, reference values or details were provided). Physician let him adjusted dosage to 16 unspecified units in the morning, 6 to 7 unspecified units at noon, and 14 unspecified units in the evening. Then, physician changed dosage to 18 unspecified units in the morning, 7 unspecified units at noon, and 16 unspecified units in the evening. The last change of dosage was 20 unspecified units in the morning, 8 unspecified units at noon, and 18 unspecified units in the evening. On an unknown date, he was hospitalized twice to adjust blood sugar. No more details regarding admission and discharge dates as well as treatment and laboratory tests done while hospitalized were provided. On another unspecified date, if he ate less in the morning, he would have hypoglycemia before noon with shivered convulsively, at the moment nigrescent and sweating. These symptoms were relieved after eating some food. On (b)(6) 2016 was the last time with hypoglycemia. At that time, the symptom relieved after eating some fruit drops. Also, the front of injection pen was broken down and could not install syringe needle (pc number (b)(4), lot number unknown). On that same date, he changed a new injection pen in (b)(6). Information regarding additional corrective treatment and outcome of the remaining events was not provided. Insulin lispro protamine suspension 50%/insulin lispro 50% treatment was continued. The operator of the device and his or her training status was not provided. The device model duration of use was since 2014. The reported device duration of use was not provided. The device was not returned. The consumer reporter did not know if the events were related the insulin lispro protamine suspension 50%/insulin lispro 50% therapy but did not provide a relatedness assessment between them and device. Edit 23may2016. Case was opened to enter medwatch device fields for device mailing. No new information. Edit 23-may-2016: upon internal review, the case was reopened in order to adding missing product complaint information to the narrative. No additional information was added to the case. Update 15-jun-2016: information regarding the pc number received on 19-may-2016 was already processed. No changes were performed in the case update 24-jun-2016: additional information received on 23-jun-2016 from the global product complaint database added the device specific safety summary; added the device was not returned; updated the medwatch and european and canadian required device reporting elements; and updated the narrative.
 
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Brand NameHUMAPEN ERGO II
Type of DeviceFOR TREATMENT PURPOSES
Manufacturer (Section D)
ELI LILLY AND COMPANY
lilly corporate center
indianapolis IN 46285
Manufacturer (Section G)
PHILLIPS-MEDISIZE CORPORATION
415 red cedar street
medical device manufacturing
menomonie WI 54751
Manufacturer Contact
caroline rosewell
lilly corporate center
indianapolis, IN 46285
3172764376
MDR Report Key5681277
MDR Text Key45972326
Report Number1819470-2016-00135
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K151686
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup
Report Date 05/09/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/26/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberMS9557
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/23/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 05/26/2016 Patient Sequence Number: 1
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