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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 Unable to Obtain Readings (1516)
Patient Problems Stroke/CVA (1770); Erythema (1840); Hair Loss (1877); Loss of Vision (2139); Coma (2417); Blood Loss (2597)
Event Date 01/18/2019
Event Type  Injury  
Manufacturer Narrative
Description of problem or event: new, updated and corrected information is referenced within the update statements. Please refer to update statement(s) dated 26jul2019. No further follow-up is planned.
 
Event Description
Lilly case id: (b)(4). This solicited case, reported by a consumer via patient support program (psp), concerns a (b)(6)-year-old female patient of unknown ethnicity. Medical history of the patient included gallstone the size of a golf ball approximately in 2001; hyperthyroidism that became hypothyroidism in 2005 due to nuclear medicine (as reported); diabetes diagnosis about in 2009; use of metformin and unspecified insulin; weight gain; coma on (b)(6) 2012; use of regular human insulin injected with a syringe, which hurt; and memory impairment. Concomitant medication included metformin for unknown indication. The patient received insulin glargine (rdna origin) (basaglar) via disposable device, 22 units, daily and human insulin nph (humulin n) unknown formulation, both at unknown route of administration, for treatment of diabetes, beginning approximately in (b)(6) 2018. Also approximately in (b)(6) 2018, the patient started receiving regular human insulin (rdna origin) (humulin r) cartridge, via humapen ergo ii, 10 units in the morning, 8 units at lunch time and 10 units in the night (dinner time), unknown route of administration, for treatment of diabetes. On unknown date, unknown time to onset, the patient experienced a little red mark at the injection site and sometimes a little drop of blood came out of the injection site. Additionally, it was stated that the patient stored in use insulins inside the refrigerator. On (b)(6) 2018, approximately four months after starting treatment with insulin glargine, human insulin nph and human insulin regular, patient experienced a cerebrovascular accident (cva) and became blind due to the cva, which were considered serious by the company due to medically significant reasons. The patient also experienced hair loss due to the cva. In (b)(6) 2019, about seven months after starting human insulin regular via humapen ergo ii, insulin glargine and human insulin nph, the patient went to the dermatologist to perform an unspecified procedure and her blood glucose was so high that the device could not measure it. Conflicting information was also provided by reporter as cva and blood glucose high happened before insulin glargine, human insulin regular and human insulin nph. In (b)(6) 2019, the patient did a blood glucose test at home, and it was high. She went to the emergency room in an ambulance and had a diabetic coma. The events of blood glucose increased and diabetic coma were considered serious by the company due to medically significant reasons. In (b)(6) 2019, the patient returned to her prescribing physician and her dosage regimen was changed to 24 units of insulin glargine in the morning, and regular human insulin was changed to 8 units in the morning, 6 units at lunch time and 8 units at night (dinner time). Information regarding corrective treatment was not provided. The patient stopped storing in use insulins inside the refrigerator on unknown date. Outcome of the remaining events was unknown. Status of insulin glargine and human insulin regular and nph was not provided. It was unknown who operated the devices and their training status. Patient had used the device models and reported devices for unknown period of time. Return status of devices and action taken were unknown. The reporting consumer did not provide any opinion of relatedness. This case is cross-referenced to the cases (b)(4) (same patient). Update 10jul2019: additional information received on 04jul2019 from initial consumer reporter. Added serious events of increased blood glucose from (b)(6) 2019, diabetic coma and blindness and non-serious event of hair loss. Narrative and corresponding fields were updated accordingly. Edit 18jul2019: updated medwatch fields for expedited device reporting. No new information added. Update 26jul2019: entered a device specific safety summary (dsss) for the humapen ergo ii device. Updated medwatch and european and (b)(4) (eu/(b)(4)) fields for expedited device reporting. 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 (Section G)
PHILLIPS-MEDISIZE CORPORATION
415 red cedar street
medical device manufacturing
menomonie WI 54751
Manufacturer Contact
chris davis
lilly corporate center
indianapolis, IN 46285
3174334585
MDR Report Key8856611
MDR Text Key153835772
Report Number1819470-2019-00130
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 08/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/02/2019
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 Received07/04/2019
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: 08/02/2019 Patient Sequence Number: 1
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