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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 Problems Failure to Zero (1683); Device Operates Differently Than Expected (2913)
Patient Problem Tissue Damage (2104)
Event Date 01/31/2014
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 of (b)(6) origin. Medical history included heart disease, cataract, eyes could not open (at first the left eye could not open, then the right eye could not open) and vision was decreased. Concomitant medication included acarbose, metformin and insulin glargine, for unknown indications and an unspecified medicine for heart disease. The patient received human insulin (rdna origin) injections (humulin r, 100u/ml) from a cartridge, 14-15 u one time but the highest dosage was 20 u, three times per day subcutaneously and beginning on an unknown date via an unspecified lilly pen. He also received insulin lispro (rdna origin) injections (humalog, 100u/ml) from a cartridge via humapen ergo ii, 6-8 u in the morning, 10-11 u at noon and 10 u in the evening, subcutaneously, beginning in 2014; both for the treatment of diabetes mellitus. In 2014, his blood glucose was not controlled well (no values, units or reference ranges were provided), his urine routine test was not normal and he was hospitalized. In 2014 his injection pen failed and the outer skin fell off (unspecified type of pen) ((b)(4), lot unknown). On an unknown date he changed human insulin to insulin lispro per physicians order. On an unknown date his humapen ergo ii dosage could not be pressed down to zero after injection and he did not inject enough insulin lispro ((b)(4), lot 1106d01). Information regarding corrective treatments, hospitalization details and outcome of the events were not provided. Human insulin was discontinued in 2014 and insulin lispro treatment was ongoing. The operator of the devices and his/her training status was not provided. The general device (unspecified lilly pen) duration of use and the duration of use were unknown. The unspecified lilly pen was discarded; therefore it would not be returned. The general humapen ergo ii duration of use was unknown but began in 2014. The suspect humapen ergo ii duration of use was not provided. It was unknown if the use of the suspect humapen ergo ii was continued. The reporting consumer did not know if the events were related to human insulin and insulin lispro and did not provide assessment of causality for the unspecified lilly pen and humapen ergo ii. Update 21-jul-2016: upon review, this case was opened to update the medwatch and european and canadian required device reporting elements for regulatory reporting, and to add the product complaint numbers to the narrative. Update 21-jul-2016: information received from the affiliate on 14-jul-2016. The event of accidental underdose happened with the humapen ergo ii and insulin lispro. Narrative and fields were updated accordingly. Edit 26-jul-2016: upon review of information received on 14-jul-2016 redaction of last update statement was updated.
 
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 22aug2016 in describe event or problem. No further follow up is planned. This report is associated with 1819470-2011-00192, since there is more than one device implicated. Evaluation summary a male patient reported his humapen ergo ii device 'failed. " 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. All humapen ergo ii devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring dose accuracy and device functionality with a high probability. 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 of (b)(6) origin. Medical history included heart disease, cataract, eyes could not open (at first the left eye could not open, then the right eye could not open) and vision was decreased. Concomitant medication included acarbose, metformin and insulin glargine, for unknown indications and an unspecified medicine for heart disease. The patient received human insulin (rdna origin) injections (humulin r, 100u/ml) from a cartridge, 14-15 u one time but the highest dosage was 20 u, three times per day subcutaneously and beginning on an unknown date via an unspecified lilly pen. He also received insulin lispro (rdna origin) injections (humalog, 100u/ml) from a cartridge via humapen ergo ii, 6-8 u in the morning, 10-11 u at noon and 10 u in the evening, subcutaneously, beginning in 2014; both for the treatment of diabetes mellitus. In 2014, his blood glucose was not controlled well (no values, units or reference ranges were provided), his urine routine test was not normal and he was hospitalized. In 2014 his first injection humapen ergo ii failed and the outer skin fell off ((b)(4), lot unknown). On an unknown date he changed human insulin to insulin lispro per physicians order. On an unknown date with his second humapen ergo ii dosage could not be pressed down to zero after injection and he did not inject enough insulin lispro ((b)(4), lot 0909d02). Additional information was not provided. Information regarding corrective treatments, hospitalization details and outcome of the events were not provided. Human insulin was discontinued in 2014 and insulin lispro treatment was ongoing. The operator of the devices and his/her training status was not provided. The general device of the first humapen ergo ii duration of use and the duration of use were unknown. The first humapen ergo ii was discarded and not returned. The second general humapen ergo ii duration of use was unknown but began in 2014. The second suspect humapen ergo ii duration of use was not provided. The device associated with (b)(4) was returned on 20jul2016, and no malfunction was found. The reporting consumer did not know if the events were related to human insulin and insulin lispro and did not provide assessment of causality for the humapens ergo ii. Update 21-jul-2016: upon review, this case was opened to update the medwatch and european and canadian required device reporting elements for regulatory reporting, and to add the product complaint numbers to the narrative. Update 21-jul-2016: information received from the affiliate on 14-jul-2016. The event of accidental underdose happened with the second humapen ergo ii and insulin lispro. Narrative and fields were updated accordingly. Edit 26-jul-2016: upon review of information received on 14-jul-2016 redaction of last update statement was updated. Update 12-aug-2016: additional information received from the affiliate on 15-jul-2016. First suspect device was changed from humapen unknown device to humapen ergo ii and a new humapen ergo ii was coded as suspect. Product complaint reference numbers were processed and added to the narrative. No adverse event information was received. Edit 16-aug-2016: upon review of information received on 14-jul-2016. Third humapen ergo ii was deleted, lot number of the second humapen ergo ii was changed from 1106d01 to 0909d02 and (b)(4) was reprocessed and added to the second pen. No other changes were performed. Update 22aug2016: additional information was received on 22aug2016 from the global product complaint database. The following was added for the device associated with (b)(4): 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. The following was added for the device associated with (b)(4); added the device specific safety summary, return date, and manufactured date of the device; updated the improper use and storage to yes; updated the malfunction field to no; 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 Key5837276
MDR Text Key50929745
Report Number1819470-2016-00193
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 07/14/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/01/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberMS9557
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/22/2016
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: 08/01/2016 Patient Sequence Number: 1
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