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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 Deliver (2338); Mechanical Jam (2983)
Patient Problems Hyperglycemia (1905); Hypoglycemia (1912)
Event Type  Injury  
Manufacturer Narrative
New, updated, and corrected information is referenced within the update statements. No further follow-up is planned. This report is associated with 1819470-2021-00110 since there is more than one device implicated. Evaluation summary: a female patient reported that the injection button of her humapen ergo ii device "was pressed down to the end at once, there was no clicking sound, the black injection screw did not move but rotated empty, insulin could not be ejected out. " on unknown dates, the patient experienced blood glucose fluctuations. The device was not returned to the manufacturer for investigation (batch number 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 with high probability. The patient reported having the device issue within the first two days of obtaining the device in 2013 and continued to use the device. The core instructions for use state if any of the parts of your humapen ergo ii appear broken or damaged, do not use. In addition, the patient used the device for approximately eight years. The core instructions for use state the humapen ergo ii has been designed to be used for up to 3 years after first use. There is evidence of improper use. The patient continued to use the device after experiencing the alleged complaint issue and used the device beyond the recommended use period. It is unknown these use issues are relevant to the event of blood glucose fluctuation.
 
Event Description
Lilly case id: (b)(6). This report is associated with product complaint: (b)(4). This spontaneous case, reported by a consumer who contacted the company to report adverse events and product complaint concerned a (b)(6) (at the time of initial report) female patient of han origin. Medical history was not reported. Concomitant medication include metformin and glucobay for unknown indication. The patient received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) (humalog mix 25, 100 u/ml) from cartridge formulation via reusable devices, humapen ergo ii, noon 30 units, 20 night twice daily, subcutaneously for the treatment of diabetes mellitus, beginning around 2008-2009. On an unknown date, after starting insulin lispro protamine suspension 75%/insulin lispro 25%, her blood glucose fluctuated a lot (values, units and reference ranges were not provided). On an unknown dates, she was hospitalized several times for regulating the blood glucose as the blood glucose fluctuated a lot. On an unknown date, first humapen ergo ii was not good to be used anymore((b)(4); lot unknown). He got a replacement in 2013, in the first two days of use, with the second humapen ergo ii, button of the humapen ergo ii was pressed down to the end at once, there was no clicking sound, the black injection screw did not move but rotated empty, insulin could not be ejected out ((b)(4); lot unknown). Patient continued to use this humapen ergo ii. (improper use). Further information regarding hospitalization, corrective treatment, outcome of event was unknown. Therapy status of insulin lispro protamine suspension 75%/insulin lispro 25% was continued. The operator of humapen ergo ii was unknown and his/her training status was not provided. The general humapen ergo ii duration of use and first humapen ergo ii duration of use was not provided and second suspect device duration of use was approximately 8 years (improper use). The action taken with suspect humapen ergo ii devices was not provided. The suspect humapen ergo ii devices (unknown lots) associated with product complaint (b)(4) and product complaint (b)(4) were not returned to the manufacturer. The reporting consumer did not know if event was related with insulin lispro protamine suspension 75%/insulin lispro 25% and did not provide relatedness of event with suspect humapen ergo ii devices. Update 23aug2021: additional information received on 19aug2021 from global product complaint database. Entered device specific safety summaries(dsss). Updated the medwatch fields with device information, the (b)(4) device information for the suspect humapen ergo ii devices (unknown lots) associated with product complaint (b)(4) and product complaint (b)(4) which were not returned to the manufacturer. Corresponding fields and narrative updated accordingly.
 
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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 Contact
chris davis
lilly corporate center
indianapolis, IN 46285
MDR Report Key12440178
MDR Text Key278327252
Report Number1819470-2021-00111
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 consumer,foreign
Type of Report Initial
Report Date 09/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/08/2021
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 Received08/10/2021
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: 09/08/2021 Patient Sequence Number: 1
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