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Model Number MS9557
Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017); Device Operates Differently Than Expected (2913)
Patient Problems Hyperglycemia (1905); Rash (2033); Reaction (2414)
Event Type  Injury  
Manufacturer Narrative
No further follow up is planned. This report is associated with 1819470-2016-00163, since there is more than one device implicated. Evaluation summary: a male patient reported that the [?]screw rod' of his humapen ergo ii device broke. The patient experienced increased blood glucose levels. The investigation of the returned device (batch (b)(4), manufactured december 2011) found that the injection foot was detached and not returned with the device. The injection screw was not broken. The foot detachment was attributed to damage while in the field and supported by evidence of unknown tool marks present on the tip of the injection screw. In addition, white foreign material was observed on the front housing threads. Although the foot was missing, the device did meet functional requirements. No malfunction was identified. It has been demonstrated that humapen ergo ii devices remain dose accurate with a detached foot. The user manual describes the proper care and storage of the device. It further instructs to not use the device if it appears broken or damaged and to contact lilly or your healthcare professional for a replacement pen. There is evidence of improper use and/or storage. The foot was purposely removed and foreign material was present. It is unknown if this is relevant to the increased blood glucose levels.
Event Description
(b)(4). This solicited case reported by a consumer via patient support program (psp) with additional information from the initial reporter via psp concerned a (b)(6) male patient. Medical history included a stroke. Concomitant medications were not provided. The patient received human insulin (rdna origin) injections (humulin ) through a cartridge via reusable pen (humapen ergo ii) 12 (no units) each morning, 12 each evening for the treatment of diabetes mellitus beginning in 2010. In (b)(6) 2015 approximately five years after beginning human insulin he experienced gall stones due to this he was hospitalized. Dates of hospitalization or further details were not provided. He also experienced itching and red lumps symptoms on the body after injected insulin. He was not recovered from the event. Additionally on unspecified date he high blood glucose, his fasting blood glucose was 10-20 (no units provided) due to this he was hospitalized, he was hospitalized every year. Dates of hospitalization or further details were not provided. Additionally on unspecified date his first humapen ergo ii had a problem with the screw rod (lot. Unknown (b)(4)) and had been replaced, and with the second humapen ergo ii the screw rod broke (lot. 1112d01 (b)(4)). Information regarding corrective treatment was unknown. Outcome for the remaining events was unknown. Insulin human treatment was continued. The operator of the humapen ergo ii and his/her training status was unknown. The general device and reported device duration of use was not provided but the started date was 2010. If device was returned, an evaluation would be performed to determine if a malfunction had occurred. The reporting consumer did not know if the events were related with the human insulin or the humapen ergo ii. Edit 23-dec-2015: upon internal review on 23-dec-2015, it was explained the term bid in narrative. No other changes were performed. Update 22-jan-2016: additional information was received on 12-jan-2016 from internal communication; it was stated that a follow up was attempt, however it was unsuccessful. No new information was added to the case. Update 04-feb-2016:information received on 25-jan-2016 stated reporter could not be contacted. No additional changes were done to the case. Update 17-feb-2016: information received on 06-feb-2016 stated reporter refused to be contacted. No additional changes were done to the case. Update 19-may-2016: additional information received in 09-may-2016 form the initial reporter. Added stroke as medical history. Added humapen ergo ii as suspect device. Added blood glucose increased as serious event. Updated narrative with new information. Update 16-jun-2016: follow up information received on 11-may-2016, included product complaint which was previously processed. No new adverse event information was added to the case. Update 29jun2016. Additional information received 28jun2016 from the product complaint safety database. To both device tabs added the device specific safety summaries (dsss), entered the european and canadian (eu/ca) device information, and entered the device medwatch information. To the second device tab changed improper use or storage to yes, malfunction to no, return date, and the manufacture date. The narrative was updated accordingly.
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Manufacturer (Section D)
lilly corporate center
indianapolis IN 46285
Manufacturer (Section G)
415 red cedar street
medical device manufacturing
menomonie WI 54751
Manufacturer Contact
caroline rosewell
lilly corporate center
indianapolis, IN 46285
MDR Report Key5798000
MDR Text Key49658691
Report Number1819470-2016-00162
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial
Report Date 12/16/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/15/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberMS9557
Device Lot Number1112D01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/13/2016
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/28/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/31/2011
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: 07/15/2016 Patient Sequence Number: 1