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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 Break (1069); Physical Resistance/Sticking (4012)
Patient Problems Hyperglycemia (1905); High Blood Pressure/ Hypertension (1908); Missed Dose (2561)
Event Date 10/02/2019
Event Type  Injury  
Manufacturer Narrative
If device is returned, evaluation will be performed to determine if a malfunction has occurred. This is an initial report. A follow up report will be submitted when the final evaluation is completed.
 
Event Description
Lilly case id: (b)(4). This report is associated with product compliant: (b)(4). This solicited case, reported by a consumer via a patient support program (psp), concerned an approximately a (b)(6) female patient of unknown ethnicity. Medical history and concomitant medications were not reported. The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) (humulin 30/70, cartridge), via a reusable pen device (humapen ergo ii), at morning 20 units and night 20 units; twice daily, subcutaneously, for the treatment of diabetes mellitus, beginning sometime in (b)(6) 2019. Sometime in (b)(6) 2019 (conflicting, also reported as (b)(6) 2019), while on human insulin 30/70 treatment, her humapen ergo ii screw was stuck and the dose adjustment did not rotate (pc number: (b)(4) and lot number: 1806d03) due to which she had missed several doses. In (b)(6) 2019, her blood pressure reached 170/100 mmhg (reference ranges were not provided) and she was diagnosed with hypertension since she missed doses (as reported). Since (b)(6) 2019, she also started to suffer from high blood glucose and that reached 600 mg/dl. Since an unknown date, she had been taking her doses with syringe. On (b)(6) 2019, her blood glucose decreased to 400 mg/dl. She was recovering from the event of blood glucose increased. Information regarding additional corrective treatment was not provided. She was not recovered from the remaining events. Human insulin isophane suspension 70%/human insulin 30 treatment was continued. The operator of the humapen ergo ii device and his/her training status was not provided. The humapen ergo ii device general model duration was not provided and the suspect humapen ergo ii device model durations of use was approximately five months (started sometime in (b)(6). The humapen ergo ii device was discontinued and its return status was expected. The reporting consumer did not relate the events of blood glucose increased and missed dose while related hypertension with human insulin isophane suspension 70%/human insulin 30% treatment and related the events with the humapen ergo ii device. Edit: 09-dec-2019: updated medwatch and european and (b)(6) (eu/(b)(6) fields for expedited device reporting. No new information added.
 
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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 Key9459598
MDR Text Key185301688
Report Number1819470-2019-00216
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,Followup
Report Date 01/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMS9557
Device Lot Number1806D03
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/26/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/30/2018
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: 12/12/2019 Patient Sequence Number: 1
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