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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 Device Operates Differently Than Expected (2913)
Patient Problems Cataract (1766); Glaucoma (1875); Retinal Degeneration (2049); Loss of Vision (2139)
Event Type  Injury  
Manufacturer Narrative
New, updated and corrected information is referenced within the update statements in describe event or problem. No further follow-up is planned. A male patient reported that his humapen ergo ii device malfunctioned, but after priming could then be used normally. The patient experienced abnormal blood glucose. The device was not returned to the manufacturer for investigation (batch number 1312d01, manufactured december 2013). Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction. Malfunction unknown. A complaint history review for the batch did not identify any atypical findings with regard to dose accuracy issues. All humapen ergo ii devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality and dose accuracy with high probability. There is no evidence of improper use or storage.
 
Event Description
(b)(4). This solicited case, reported by a consumer via a patient support program (psp), concerned a (b)(6) (at the time of the initial report) asian male patient. Medical history included hemiplegia. Concomitant medications calcium hydroxybenzoate and ginaton (as reported), both used for unknown indication. The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) injections (humulin 70/30, 100 u/ml) from cartridge via a reusable device (humapen ergo 2), subcutaneously for the treatment of diabetes mellitus beginning approximately on an unknown date in 2013 or 2014 (conflicting information provided). On an unknown date, after starting of human insulin isophane suspension 70%/human insulin 30% therapy, he subsequently had diabetic macular degeneration, acute glaucoma, slight cataract in both eyes, blindness in the right eye and had a little vision in his left eye. The events of macular degeneration, angle closure glaucoma and blindness were considered as serious due to medically significant reason. On an unknown his blood glucose was not regulated (values and reference range were not reported). Approximately in 2015 or 2016 (conflicting information provided), he was admitted into the hospital to regulate his blood glucose. While he was in the hospital, his physician advised to change into insulin lispro protamine suspension 50%/insulin lispro 50%, 14 or 15 units (conflicting information provided) and on an unknown date the dose was changed to 18 units in the morning and 18 units in night and as on (b)(6) 2018 it was continued. Information regarding hospitalization dates, lab examination findings, corrective treatment and outcome of the events was not reported. It was unknown if human insulin isophane suspension 70%/human insulin 30%, therapy would be restarted. The operator of the humapen ergo 2 and his/her training status were not provided. The general humapen ergo 2 model duration of use was not provided but it started approximately in 2013 or 2014 (conflicting information provided). The humapen ergo 2 was still in use. If humapen ergo 2 was returned, evaluation would be performed to determine if a malfunction had occurred. The reporting consumer was not sure for relatedness of the events with human insulin isophane suspension 70%/human insulin 30% treatment, did not provide relatedness with the humapen ergo 2. Edit 22mar2018: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting. No new information added. Update 11apr2018: additional information received on 11apr2018 from the global product complaint database. Entered device specific safety summary (dsss). Updated the medwatch/european and canadian (eu/ca) device information and device return status to not returned to manufacturer. Added date of manufacturer for (b)(4) associated with lot 1312d01 of humapen ergo ii device. Corresponding fields and narrative updated accordingly.
 
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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 Key7426645
MDR Text Key105935200
Report Number1819470-2018-00045
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
Report Date 04/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberMS9557
Device Lot Number1312D01
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/16/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/31/2013
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: 04/12/2018 Patient Sequence Number: 1
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