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Model Number MS9557
Device Problems Insufficient Flow or Under Infusion (2182); Device Operates Differently Than Expected (2913)
Patient Problems Hyperglycemia (1905); Underdose (2542)
Event Date 05/07/2018
Event Type  Injury  
Manufacturer Narrative
Narrative field: new, updated and corrected information is referenced within the update statements in describe event or problem. No further follow-up is planned. Evaluation summary: a male patient reported that the injection button of his humapen ergo ii device could not be pushed down and insulin could not be injected. He experienced increased blood glucose. The device was not returned 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 device functionality and dose accuracy with high probability. There is no evidence of improper use.
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). Medical history of combined disease and allergic history, previous drug adverse reaction and family drug reaction were none. Family medical history included diabetes of sister. Concomitant medication was none. The patient received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) injections (humalog mix 25, 100 u/ml) from cartridge via reusable device (humapen ergo ii), twice daily (morning 24 units, night 8 units) subcutaneously for the treatment of type 2 diabetes mellitus, beginning on (b)(6) 2018. On (b)(6) 2018, 20 or 21 days after starting insulin lispro protamine suspension 75%/insulin lispro 25%, he did not inject enough insulin lispro protamine suspension 75%/insulin lispro 25% according to physicians order due to breakdown of humapen ergo ii (pc 4352908/ lot number unknown). Further described, the injection button of the humapen could not be pushed down after pressed half and the number in dose window cannot be returned to zero; insulin cannot be injected as normal, the humapen cannot rotate and work normally. On (b)(6) 2018, he was hospitalized as the he did not inject insulin lispro protamine suspension 75%/insulin lispro 25% on the advice of physician. On (b)(6) 2018, his blood glucose was measured at more than 36 (no units or reference ranges were provided). He thought the blood glucose was high. He stopped using insulin lispro protamine suspension 75%/insulin lispro 25% on the physicians advice after admission to hospital. On an unknown date, he was recovering from the events. Information regarding corrective treatment was not provided. It was unknown if the insulin lispro protamine suspension 75%/insulin lispro 25% therapy would be restarted. The patient was the operator of the humapen ergo ii and his training status was not provided. The humapen ergo ii model duration of use and the suspect humapen ergo ii duration of use was 20 days. The suspect humapen ergo ii device associated with (b)(4) was not returned to the manufacturer. The reporting consumer did not provide a relatedness assessment for the events to insulin lispro protamine suspension 75%/insulin lispro 25%; it was noted the patient did not inject enough insulin due to humapen device, no other relatedness assessment for the device was provided. Update 10-may-2018: this case was determined to be non-valid as there was no identifiable product. Update 16-may-2018: additional information was received on 10-may-2018 from initial reporter via psp and on 14-may-2018 from rcp were processed together. This case was upgraded to serious due to addition of the serious event of blood sugar increased. Also, this case was initially determined to be non-valid (no valid suspect product identifiable), the follow up received contained a valid suspect product. Added laboratory data and stop date of insulin lispro protamine suspension 75%/insulin lispro 25%. Updated the coding for suspect drug to insulin lispro protamine suspension 75%/insulin lispro 25% cartridge, suspect device from humapen unknown body type to humapen ergo ii, start date for suspect drug, action taken to drug discontinued, dechallenge positive, suspect device age, description as reported and outcome for the event of wrong dose administered. Updated the narrative with new information. Update 21may2018: updated medwatch fields for expedited device reporting. No new information added. Update 30may2018: additional information received on 25may2018 from the global product complaint database. Entered device specific safety summary (dsss). Updated the medwatch fields with device information, the european and canadian (eu/ca) device information, and device relatedness summary in narrative for not injecting enough insulin (insulin not injected as normal) from not reported to related to the humapen ergo ii device. Noted suspect humapen ergo ii associated with (b)(4) was not returned to the manufacturer. Corresponding fields and narrative 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
chris davis
lilly corporate center
indianapolis, IN 46285
MDR Report Key7557668
MDR Text Key109702303
Report Number1819470-2018-00093
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,Followup
Report Date 06/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/31/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMS9557
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/10/2018
Was Device Evaluated by Manufacturer? No
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: 05/31/2018 Patient Sequence Number: 1