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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 Crack (1135); Mechanical Jam (2983); Scratched Material (3020); Physical Resistance/Sticking (4012); Device Fell (4014)
Patient Problem Hyperglycemia (1905)
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. This report is associated with 1819470-2021-00026 since there is more than one device implicated.
 
Event Description
Lilly case id: (b)(4). This report is associated with product complaint: (b)(4). This spontaneous case, reported by consumer who contacted the company to report adverse events and product complaints (pc), concerned an asian male patient of an unknown age. Medical histories included coronary heart disease, eczema, problem of lung, gastritis, the cerebrovascular disorder, lumbar disc herniation, lumbar vertebra and cervical vertebra were not good. Her mother had diabetes mellitus and esophageal cancer. Concomitant medications included metformin, acarbose and gliclazide, all used for type 2 diabetes mellitus. The patient received insulin lispro (rdna origin) from a cartridge via a reusable pen (humapen ergo ii), at a dose of 8-16iu daily, subcutaneously for the treatment of type 2 diabetes mellitus, beginning on an unknown date in 2001 or 2015 (conflicting information was provided). On an unknown date, his humapen ergo ii (which was received in 2014) fell and cracked accidentally (pc number: (b)(4); lot number: unknown). On an unknown date, while on insulin lispro therapy, he experienced dizziness and high blood glucose (exact values, units and reference ranges were not provided). On an unknown date, he had coronary heart disease (possible aggravation) and high blood glucose which required hospitalisation for ten time in 2020 (specific time of each hospitalization was not provided). He had the conditions of dizziness, weakness in all four limbs, blurred eyes, diabetes was severe and could not remember. When sometimes the blood glucose was severe (unspecific time), he would changed the dosage of insulin lispro by self, from 8iu each time to 12 or 13iu (unspecific time). In (b)(6) 2020, he changed to another cartridge of insulin lispro and the glass of the cartridge was cracked (pc (b)(4)/ lot number unknown). Also, the outside of the second humapen ergo ii (which was received in 2015) only had slight scratch, but the injection button could not be pressed down (pc (b)(4)/ lot number 0712d04). Information regarding the corrective treatment, outcome of the events and insulin lispro therapy status was not provided. The suspect devices action taken was not provided. The operator of the humapen ergo ii devices was the patient and his training status was not provided. The humapen ergo ii devices general model duration of use were not provided. The first suspect humapen ergo ii device duration of use was six years as it was started in 2014 (it was considered as improper use of device). The second suspect humapen ergo ii duration of use was five years as it was started in 2015 (it was considered as improper use of device). The action taken with humapen ergo ii devices were not provided. The suspect device with pc (b)(4) was not returned to the manufacturer; other suspect device with pc (b)(4) return status was not provided. The initial reporting consumer did not provide a relatedness assessment for the events with insulin lispro drug, and/or suspect humapen ergo ii devices. Update 01-feb-2021: all information received on 26-jan-2021 and 27-jan-2021 were processed together at the same time. Edit 04-feb-2021: upon review of the information received on 26-jan-2021, case was routed for medical review. Updated as determined causality to no for the events dizziness and blood glucose increased. No other changes were made to the case. Update 09-feb-2021: additional information was received from initial reporter on 03-feb-2021 and 04-feb-2021 were processed together. This case was upgraded to serious as the event of blood glucose increased was upgraded to serious and serious event of coronary heart disease was added. Added laboratory data, medical history (lumbar disc herniation), second suspect humapen ergo ii device, eu/(b)(6) fields for the first suspect humapen ergo ii, additional dosage regimen for insulin lispro therapy with updated dose and non-serious events (weakness in all four limbs, dizziness, blurred eyes, diabetes was severe and could not remember). Updated the medical history coding of familial risk factor. Updated the causality statement and narrative with new information. Upon review of the case, updated the improper use of first suspect humapen ergo ii as yes and added its device age. Update 10feb2021: additional information received on 09feb2021 from the global product complaint database. Entered device specific safety summary (dsss). Updated the medwatch fields/ european and (b)(6) (eu/(b)(6)) device information, and device return status to not returned to manufacturer for pc (b)(4) associated with unknown lot of humapen ergo ii device. Corresponding fields and narrative updated accordingly. Edit 11feb2021: 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
MDR Report Key11332481
MDR Text Key240466706
Report Number1819470-2021-00025
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 02/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMS9557
Device Lot Number0712AD04
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/15/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/31/2007
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: 02/16/2021 Patient Sequence Number: 1
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