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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN, UNKNOWN DEVICE FOR TREATMENT PURPOSES

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ELI LILLY AND COMPANY HUMAPEN, UNKNOWN DEVICE FOR TREATMENT PURPOSES Back to Search Results
Model Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Infarction, Cerebral (1771); Dizziness (2194); Confusion/ Disorientation (2553)
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
(b)(4). This solicited case, reported by a consumers via a patient support program (psp), concerned a (b)(6)-years old (at the time of initial report) male patient of han nationality. Medical history (complicating disease, allergic history and family medical history) included hand tremor, parkinsons disease and his younger sister and brother had diabetes mellitus. Drug adverse reaction history and family drug adverse reaction were none. Concomitant medication included acarbose for the treatment of type-2 diabetes mellitus statin (unspecified), acetylsalicylic acid and so on for the treatment of unknown indication. The patient received insulin lispro protamine suspension 50%/insulin lispro 50% (rdna origin) injections (humalog mix 50, 100iu/ml) from a cartridge via an unspecified insulin injection pen (humapen unknown body), at a dose of 20units to 22 units in morning and 20 units at night, twice daily (bid), subcutaneously, for the treatment of type-2 diabetes mellitus, beginning on an unknown date in 2014 or 2015 (five or six years ago as of 07-apr-2020). On an unknown date in 2018, while on insulin lispro protamine suspension 50%/insulin lispro 50% therapy, he had a situation of unable to remember the things and brain atrophy. The event of brain atrophy was considered as serious by the company due to medical significance reason. On an unknown date, while on insulin lispro protamine suspension 50%/insulin lispro 50% therapy, he experienced uncontrolled blood glucose (unit, reference range and value were not provided), dizziness, soft legs and cerebral infarction due to which he was hospitalized on (b)(6) 2020. Due to the events, his insulin lispro protamine suspension 50%/insulin lispro 50% dose had been changed to decreased dose of 20units to 22units in morning and 14 units at night, according to the advice of his doctor. Reportedly on an unknown date, the scale on the dose window of humapen, unknown device was cloudy (product complaint number (b)(4)/ lot number unknown). As of 13-apr-2020, cerebral infarction was related to, which cause the increase of waste in blood. Information regarding corrective treatments, further hospitalization details and outcome of the events was not provided. Insulin lispro protamine suspension 50%/insulin lispro 50% therapy was continued at decreased dose. The operator of the humapen unknown device and his/her training status were not provided. The general model humapen unknown device duration of use was not provided. The suspect humapen unknown device duration of use five years as it was started in 2015. The action taken with suspect humapen unknown device was discontinued on a unknown date and its return status was not provided. The initial reporting consumers did not provide the relatedness assessment between the events and insulin lispro protamine suspension 50%/insulin lispro 50% drug and humapen unknown device. Update 13-apr-2020: additional information was received on 07-apr-2020 from second consumer reporter contained product complaint (pc) information and number. Pc number was already processed and eu/ca field was updated with the information regarding from where was the device purchased. Upon review of the case, added device age. Updated the narrative accordingly. Update 16-apr-2020: additional information was received from the initial reporting consumer on 13-apr-2020 via psp. Added one non-serious event of blood disorder. Added concomitant drug acetyl salicylic acid. Updated causality statement and narrative with new information. Edit 28apr2020: 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, UNKNOWN DEVICE
Type of DeviceFOR TREATMENT PURPOSES
Manufacturer (Section D)
ELI LILLY AND COMPANY
lilly corporate center
indianapolis, in
Manufacturer Contact
chris davis
lilly corporate center
indianapolis, in 
4334585
MDR Report Key10006296
MDR Text Key198177403
Report Number1819470-2020-00042
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup
Report Date 05/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/01/2020
Was Device Evaluated by Manufacturer? No
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: 04/28/2020 Patient Sequence Number: 1
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