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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); Fluid Leak (1250); Mechanical Jam (2983); Physical Resistance/Sticking (4012)
Patient Problems Syncope (1610); Hyperglycemia (1905); Hypoglycemia (1912); Visual Impairment (2138); Loss of consciousness (2418); Shaking/Tremors (2515); Sleep Dysfunction (2517); Weight Changes (2607)
Event Type  Injury  
Manufacturer Narrative
If device is returned, evaluation will be performed to determine if a malfunction has occurred. A follow-up report will be submitted when the final evaluation is completed as necessary.
 
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 adverse events and product complaint (pc), concerned a (b)(6)-year-old (at the time of initial report) asian male patient. There were no medical history and concomitant medications. The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) injections (humulin 70/30, 100u/ml), through cartridge via humapen ergo ii, (morning 14, night 12; twice a day) subcutaneously for the treatment of diabetes mellitus beginning on an unknown date in 2018. On an unknown date, while on human insulin isophane suspension 70%/human insulin 30% therapy, because the blood glucose was not controlled well, it was fluctuating as it was suddenly high and suddenly low (blood glucose was 17,18 when it was high, low blood glucose value was not provided). Changed the injection dose by self from prescribed dose (morning 14, night 12) to injected morning 16, night 14 when blood glucose was low, and injected morning 18, night 14 when blood glucose was high. On unknown dates, several times he passed out (fainted) during sleeping when blood glucose was low. He experienced loss of consciousness for three to four times at night when got up to urinate (specific dates were unknown). For the first and second time, he was sent to hospital by family member, and the blood glucose value was measured at 2-3 (no units were provided) at the hospital, the doctor said it was caused by hypoglycemia and made him to take some food. When the loss of consciousness occurred, he also developed trembling. He thought the hypoglycemia might be caused by the dose injected in the evening was too much (14 units) or eating less in dinner. The hypoglycemia, blood glucose decreased, trembling and passed out were considered as symptom associated with the diagnosis of hypoglycemic unconsciousness. Since an unknown date, he could not fall asleep and due to that the weight was decreased, it was 64kg before when it was normal, then it became 61. 5kg-62kg. Since an unknown date, the eyes could not see clearly and it was caused by diabetes. On (b)(6) 2020, the humapen ergo ii syringe had two drops of liquid leakage before injection and it was jammed when injecting (pc (b)(4), lot 1404d01), sometimes the injection button of the humapen ergo ii could not be pressed in the middle of injection. During injection, the injection button of the humapen ergo ii was stuck when he tried to press in the last two to three days. He changed insulin needle once for every two insulin cartridges and he kept his insulin pen with needle inside the fridge (it was considered as improper use of the humapen ergo ii). Because the insulin syringe was broken, so he suspected the injection dose was inaccurate. Corrective treatments were not reported. Outcome of the event blood glucose fluctuation was recovering, event could not fall asleep was not recovered while outcome of remaining events were unknown. Therapy with human insulin isophane suspension 70%/human insulin 30% was ongoing. The operator of the humapen ergo ii was patient and his training status was not provided. The general humapen ergo ii model duration of use was not provided. Suspect humapen ergo ii duration of use was approximately four years as it started approximately in 2016. The action taken with suspect humapen ergo ii was ongoing and its return status was not provided. The reporting consumer related the event of hypoglycemic unconsciousness to human insulin isophane suspension 70%/human insulin 30% therapy and did not know if the remaining events were related to human insulin isophane suspension 70%/human insulin 30% therapy. The reporting consumer related the event of inaccurate dose to humapen ergo ii device while did not provide relatedness of the remaining events to humapen ergo ii. Edit 30-jun-2020: upon review of information received on 17-jun-2020, as determined causality has been updated for the event of weight decreased to no. No other changes has been made to the case. Update 01-jul-2020: additional information received from global product complaint department on 23-jun-2020 and 30-jun-2020 were processed together on the same date. Added a new non-serious event of blood glucose fluctuation (removed the event of blood glucose high), updated the non-serious event of blood glucose low to serious and updated its outcome to unknown, updated listedness of the event passed out, updated operator of device. Updated eu/ca fields and narrative with new information. Update 06-jul-2020: additional information was received from initial reporter on 01-jul-2020. Added laboratory data and serious event of hypoglycemic unconsciousness (the events of blood glucose decreased and passed out were subsumed as the diagnosis was reported). Updated the causality statement and narrative with new information. Upon review of the case, added the age of the suspect humapen ergo ii. Edit 08jul2020: 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)
TECH GROUP NORTH AMERICA INC. DBA WEST
640 south rockford drive
tempe AZ 85281
Manufacturer Contact
chris davis
lilly corporate center
indianapolis, IN 46285
3174334585
MDR Report Key10248316
MDR Text Key204060872
Report Number1819470-2020-00081
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 08/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMS9557
Device Lot Number1404D01
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/04/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/30/2014
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: 07/08/2020 Patient Sequence Number: 1
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