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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 Mechanical Problem (1384)
Patient Problem Hyperglycemia (1905)
Event Date 06/30/2020
Event Type  Injury  
Manufacturer Narrative
No further follow-up is planned. This report is associated with 1819470-2020-00134 since there is more than one device implicated. Evaluation summary: a female patient reported that her humapen ergo ii "had liquid leakage. " she experienced abnormal blood glucose. 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. The patient reported that she had used the device for more than 10 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 used the device beyond the recommended use period. It is unknown if the misuse is relevant to the event of abnormal blood glucose.
 
Event Description
Lilly case id: (b)(4). This report is associated with product complaint: (b)(4). This spontaneous case, reported by a consumer, who contacted the company to report an adverse event and a product complaint (pc), concerned a (b)(6) (at the time of initial report) asian female patient of (b)(6) nationality. Medical history included lung cancer. Concomitant medications included metformin hydrochloride, glimepiride and acarbose; all taken for diabetes mellitus. The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) (humulin 30/70, 100u/ml) from a cartridge, via blue color reusable pen device (humapen ergo ii) which was started approximately sometime in 2005 (reported as 10-20 years ago), at 14 units in morning and 18 units at night, twice daily, subcutaneously, for diabetes mellitus, beginning on an unknown date. The patient also received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) (humalog 25, 100u/ml) from a cartridge, via blue color reusable pen device (humapen ergo ii), at 10 units in morning and 14 units at night, twice daily, subcutaneously, for diabetes mellitus, beginning on an unknown date. Sometime in (b)(6) 2020, while on human insulin 70/30 and insulin lispro 75/25 treatments that were alternatively used, her blood glucose was not too good (pre-prandial blood glucose value was 10-20, postprandial was 23, units and range not provided) due to which she was hospitalized for regulating the blood glucose sometime in (b)(6) 2020 for half a month (15 days) and was discharged in the same month. Sometime in (b)(6) 2020, her humapen ergo ii had liquid leakage (pc: (b)(4) ; lot: unknown) due to which it was discontinued and the long duration of approximately 15 years of usage was considered as an improper use. And a new humapen ergo ii was started and was used until the time of report. Sometime in 2020, few months ago, the cartridge holder of the second humapen ergo ii was cracked (pc: (b)(4); lot: 1810d04). Information regarding additional corrective treatment and exact hospitalization details was not provided. The outcome for the event was not reported. Human insulin 70/30 and insulin lispro 75/25 treatments were continued. The operator of the humapen ergo ii devices and his/her training status was not provided. The first humapen ergo ii device general model duration and suspect humapen ergo ii device model duration of use approximately 15 years (which was started sometime 10-20 years ago) while the second humapen ergo ii device general model duration and suspect humapen ergo ii device model duration of use approximately was 15 days (started sometime in (b)(6) 2020). The first humapen ergo ii was discontinued sometime in (b)(6) 2020 and the second humapen ergo ii was continued. The first humapen ergo ii device (unknown lot) associated with (b)(6) was not returned to the manufacturer. The second humapen ergo ii device (lot 1810d04) associated with (b)(4) was returned to the manufacturer. The reporting consumer did not provide any relatedness for the event with human insulin 70/30 and insulin lispro 75/25 treatments and its humapen ergo ii devices. Update 02-oct-2020: information was received on 27-sep-2020 from the affiliate provided the product complaint (pc) number (b)(4) and (b)(4) and pc was processed accordingly. Updated status of second humapen ergo ii device in respect to product complaint (cartridge holder cracked) and narrative with new information. Edit 05oct2020: updated medwatch fields for expedited device reporting. No new information added. Update 12oct2020: additional information received on 11oct2020 from global product complaint database. Changed the lot number from unknown to 1810d04 for product complaint (b)(4) relating to the humapen ergo ii device. Corresponding fields and narrative updated accordingly. Update 14oct2020: additional information received on 14oct2020 from the global product complaint database. Entered device specific safety summary (dsss). Updated the medwatch fields with device information and the european and (b)(6) (eu/(b)(6)) device information for the humapen ergo ii device (unknown lot) associated with (b)(4) which was not returned to the manufacturer. Updated device return status to returned to manufacturer and added date returned to manufacturer for the humapen ergo ii device (lot 1810d04) associated with (b)(4). 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
3174334585
MDR Report Key10707552
MDR Text Key216611286
Report Number1819470-2020-00135
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
Report Date 10/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberMS9557
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/27/2020
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: 10/20/2020 Patient Sequence Number: 1
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