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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 Type  Injury  
Manufacturer Narrative
Narrative field: new, updated, and corrected information is referenced within the update statements in please refer to update statement(s) dated 27aug2021. No further follow-up is planned. Evaluation summary: a female patient reported that her humapen ergo ii device "could not be used" (unspecified issue). The patient experienced increased 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. 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. There is no evidence of improper use or storage.
 
Event Description
Lilly case id: (b)(6). This report is associated with product complaint: (b)(4). This solicited case, reported by a consumer via a patient support program (psp), concerned a (b)(6) female patient of unknown origin. Medical history included father and mother had diabetes. Concomitant medications was not reported. The patient received insulin lispro protamine suspension 50%/insulin lispro 50% (rdna origin) injection (humalog 50) from cartridge via humapen ergo ii re-usable device, 14 units twice daily, subcutaneously, for the treatment of diabetes mellitus, beginning somewhere on 2006. On an unknown date in 2020, she got hospitalized due to high blood glucose with fasting blood glucose range 10-20 mmol/l and got discharged on an unknown date (pc number: (b)(4); lot number: unknown). On an unknown date in 2021, she again her blood glucose was high and poorly controlled. Information regarding the corrective treatment was not provided. She was not recovered from the non-serious episode of high blood glucose. Outcome of the remaining event was not provided. Insulin lispro protamine suspension 50%/insulin lispro 50% therapy was continued. The operator of the humapen ergo ii device and his/ her training status was not provided. The general humapen ergo ii model duration of use was not provided but it was started somewhere in 2019. The duration of use of suspect humapen ergo ii device was unknown. The action taken with suspect humapen ergo ii was not provided and its return was not reported. The reporting consumer did not provide the relatedness assessment between the events and the insulin lispro protamine suspension 50%/insulin lispro 50% or suspect humapen ergo ii device. Update (b)(6) 2021: this case was determined to be non-valid due to non- valid as there was no identifiable suspect product. Update (b)(6) 2021: additional information was received from initial reporter via patient support program (psp) on (b)(6) 2021. Patient was hospitalized for an unknown reason on an unknown date after use of unknown insulin and has been discharged now. Added a suspect reusable device humapen ergo ii. Processed pc number (b)(4) accordingly. Updated the date of birth of the patient from feb-1964 to 01-feb-1964, start date of drug from 2016 to 2006, frequency from unknown to bid and narrative with the new information. The case still remains non-valid for no valid identifiable suspect product. Update (b)(6) 2021: initially this case was determined to be non-valid non-serious case. Additional information received on (b)(6) 2021, from initially reporter via psp, which upgrade and validated the case. Added the identifiable company suspect drug with updated action taken. Added one serious event of blood sugar increased, eu/ca fields and laboratory data. Updated the outcome from unknown to not recovered for the previously coded non-serious event of high sugar. Updated the narrative with all the new information. Update (b)(6) 2021: additional information received on (b)(6) 2021 from the global product complaint database. Entered device specific safety summary (dsss). Updated the medwatch fields/ european and canadian (eu/ca) device information, and device return status to returned to manufacturer for (b)(4) associated with unknown lot of humapen ergo ii device. Corresponding fields and narrative updated accordingly. Edit (b)(6) 2021: upon internal review, changed location of blood glucose values to free text area.
 
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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)
ELI LILLY AND COMPANY
lilly corporate center
indianapolis IN 46285
Manufacturer Contact
chris davis
lilly corporate center
indianapolis, IN 46285
MDR Report Key12463318
MDR Text Key272889843
Report Number1819470-2021-00115
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 09/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/13/2021
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 Received08/20/2021
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: 09/13/2021 Patient Sequence Number: 1
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