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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); Loose or Intermittent Connection (1371); Insufficient Flow or Under Infusion (2182); Inaccurate Delivery (2339); Material Twisted/Bent (2981); Physical Resistance/Sticking (4012); Device Fell (4014)
Patient Problem Hyperglycemia (1905)
Event Type  Injury  
Manufacturer Narrative
Since the device is not being returned, evaluation for a malfunction is not possible. A follow-up report will be submitted when the final evaluation is completed as necessary. This report is associated with 1819470-2021-00046 and 1819470-2021-00047 since there is more than one device implicated.
 
Event Description
(b)(4). This solicited case reported by a consumer via a patient support program (psp), concerned a (b)(6)-year-old (at the time of initial report) male patient of unknown ethnicity. Medical history included obesity. Concomitant medication were not reported. The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) (humulin 70/30; 100 u/ml), injections, from a cartridge via a reusable devices (humapen savvio 3ml red) and (humapen ergo ii), subcutaneously, for the treatment of diabetes mellitus, beginning approximately in 2005 (reported as 16 years prior to mar-2021). Dose and frequency, were not provided. Since an unspecified date, possibly while on human insulin isophane suspension 70%/human insulin 30% therapy, he was experiencing high blood glucose level which resulted in shivering while attaching the needle to take his dose; always suffered from high blood glucose level around 500 to 600 mg/dl and that they were measuring his blood glucose levels every two hours as it sometimes became unstable, decreased and increased as per food intake, he was taking 10 iu from human insulin isophane suspension 70%/human insulin 30% therapy and 10 iu from another insulin (apride as spelled it) when blood glucose level reached 500 mg/dl till it decreased to 200 mg/dl, as his physician advised. The blood glucose of 500 mg/dl event was considered to be serious by the company due to its medical significance. His first humapen was savvio red, it got impaired, they were keeping it in the refrigerator. Then his health care professional (hcp), gave him another humapen ergo ii when savvio got impaired but this ergo ii got broken as it fell on the ground while he was trying to take his dose, due to shivering which caused falling of humapen ergo ii on the ground. Things always fall form him while he was trying to attach parts of humapens to take his doses. When ergo ii got broken they tried to use first humapen savvio red but found that it was impaired as the screw was stuck when pressing to take the dose no human insulin isophane suspension 70%/human insulin 30% was released,therefore possibly he did not administered his dose (pc (b)(4)/lot number unknown and (b)(4)/lot number unknown). When they found these two humapens (savvio red and ergo ii), were not working, they got back to hcp and she gave them another humapen ergo ii. This humapen might be impaired as when he put the cartridge and closed it, it did not attach well which caused human insulin isophane suspension 70%/human insulin 30% therapy leakage and he thought that he did not take the dose so he re-took the dose again therefore possibly he received an inaccurate dose even possibly received an overdose((b)(4)/lot number unknown). They would check if the last humapen ergo ii was really impaired or not when he takes his evening dose. He was fat and the needle sometimes bent inside his body while taking the dose, also he was always anger. Finally, when the first humapen (possibly savvio red) got impaired they shifted to another insulin types as per physicians advice but these types were not effective for his case, so they returned back to human insulin isophane suspension 70%/human insulin 30% therapy, after returning to human insulin isophane suspension 70%/human insulin 30% therapy, they tried to insert the cartridge in another pen (non-company pen) but it did not fit. By (b)(6) 2021, he was not recovered from the events. Information regarding further corrective treatments, and additional details were not provided. Human insulin isophane suspension 70%/human insulin 30% therapy was on-going. The patient was the operator of the reusable devices and his training status was not provided. The general humapen savvio 3ml red and humapens ergo ii model duration of use were not reported. The suspect humapen savvio 3ml red and humapens ergo ii duration of use was unknown. The action taken with the suspects humapen savvio 3ml red and humapens ergo ii was not provided; since the device is not being returned, evaluation for a malfunction is not possible. The reporting consumer did not provide a relatedness assessment between the events and the reusabless humapen savvio 3ml red and humapens ergo ii. Edit 25-mar-2021: upon internal review on 24-mar-2021 of the initial information the cire report was attached in order to confirm the reusables humapens are ergo ii for the pcs (b)(4), the device componen information fields from humapens ergo ii were deleted, and the coding from the medication error of patient possible administered wrong humulin 70/30 dose due to a possible device issue, no ae was corrected from wrong drug administered to wrong dose administered and pc (b)(4) was processed properly. Edit 26mar2021: updated medwatch and european and (b)(6) (eu)/ca) 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 Contact
chris davis
lilly corporate center
indianapolis, IN 46285
MDR Report Key11575321
MDR Text Key253503358
Report Number1819470-2021-00045
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 04/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMS9557
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/02/2021
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: 03/26/2021 Patient Sequence Number: 1
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