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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 Activation, Positioning or Separation Problem (2906)
Patient Problems Hyperglycemia (1905); Memory Loss/Impairment (1958); Cognitive Changes (2551)
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 report will be submitted when the final evaluation has been completed.
 
Event Description
(b)(4).This solicited case, reported by a consumer via a patient support program (psp), with additional information from the initial reporter via psp, concerned an asian male patient of an unknown age.Medical history and concomitant medications were not provided.The patient received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) (humalog mix 25) unknown, via a reusable device (humapen unknown), six units in morning, noon and night, via subcutaneous route, beginning on an unknown date (reportedly; approximately since the spring festival).Information regarding indication of use was not provided.On an unknown date, but after starting insulin lispro protamine suspension 75%/insulin lispro 25% therapy, his blood glucose was high (units an values were not provided) and therefore, was hospitalized several times.Hospitalization dates were not provided.On an unknown date, approximately between (b)(6) 2019 and (b)(6) 2019, after starting with therapy his brain was not healthy and the memory was bad.Reportedly the patient mental went wrong and memory turned bad (no further information was provided for the above).Approximately on (b)(6) 2019 he was hospitalized for unknown reason and as of (b)(6) 2019 had not been discharged.At the time of initial report he had 17 days hospitalized.On an unspecified date, due to a problem with the humapen unknown the patient could not inject himself, the injection screw was lost (pc: 4787282 / lot: unknown).Information regarding corrective treatment was not provided.Outcome of the events was unknown.Treatment status of insulin lispro protamine suspension 75%/insulin lispro 25% was ongoing.The operator of humapen unknown was patient and his training status was not provided.The general and suspect humapen device duration of use were not reported.As of(b)(6) 2019 the humapen unknown had been used for about six months.The status of suspect device was unknown and its return was not provided.The reporting consumer did not provide a relatedness assessment between events and insulin lispro protamine suspension 75%/insulin lispro 25% drug.The reporting consumer related the event of drug dose omission to the humapen unknown and did not provide any other causality opinion.Update 03-jul-2019: additional information received on (b)(6) 2019 from the initial reporter via psp and responsible complaint person (rcp).This case was upgraded due to the serious event of blood glucose increased.The previous non-serious event of blood glucose increased was upgraded to serious due to hospitalization.Added the non-serious event of drug dose omission.The suspect device was updated from humapen unknown to humapen ergo ii.Added ethnicity of the patient, eu/ca fields, hospitalization details, approximate start date of the humapen ergo ii and laboratory data.Updated description as reported of the event of memory impairment and the narrative with the new information.Edit 08jul2019: updated medwatch and european and (b)(4) fields for expedited device reporting.No new information added.Edit 09-jul-2019: upon review for device submission suspect device was updated from humapen ergo ii to humapen unknown.Narrative and fields were updated accordingly.
 
Manufacturer Narrative
B.5.Narrative field: new, updated and corrected information is referenced within the update statements in b.5.Please refer to update statement(s) dated (b)(6) 2019 in the b.5.Field.No further follow-up is planned.Evaluation summary: a male patient reported that he could not inject himself using his humapen (unspecified device) and "the injection screw was lost." the patient experienced increased blood glucose.The device was not returned to the manufacturer for investigation (batch number unknown).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.All humapen 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
Lilly case id:(b)(4).This solicited case, reported by a consumer via a patient support program (psp), with additional information from the initial reporter via psp, concerned an asian male patient of an unknown age.Medical history and concomitant medications were not provided.The patient received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) (humalog mix 25) unknown, via a reusable humapen (unknown) device, six units in morning, noon and night, via subcutaneous route, beginning on an unknown date (reportedly; approximately since the spring festival).Information regarding indication of use was not provided.On an unknown date, but after starting insulin lispro protamine suspension 75%/insulin lispro 25% therapy, his blood glucose was high (units an values were not provided) and therefore, was hospitalized several times.Hospitalization dates were not provided.On an unknown date, approximately between (b0(6) 2019 and (b)(6) 2019, after starting with therapy his brain was not healthy and the memory was bad.Reportedly the patient mental went wrong and memory turned bad (no further information was provided for the above).Approximately on (b)(6) 2019 he was hospitalized for unknown reason and as of (b)(6) 2019 had not been discharged.At the time of initial report he had 17 days hospitalized.On an unspecified date, due to a problem with the humapen unknown the patient could not inject himself, the injection screw was lost (b)(4)./ lot: unknown).Information regarding corrective treatment was not provided.Outcome of the events was unknown.Treatment status of insulin lispro protamine suspension 75%/insulin lispro 25% was ongoing.The operator of humapen unknown was patient and his training status was not provided.The general device duration of use was not reported.As of (b)(6) 2019 the humapen unknown had been used for about six months.The suspect device was not returned to the manufacturer.The reporting consumer did not provide a relatedness assessment between events and insulin lispro protamine suspension 75%/insulin lispro 25% drug.The reporting consumer related the event of drug dose omission to the the humapen unknown and did not provide any other causality opinion.Update (b)(6) 2019: additional information received on 27-jun-2019 from the initial reporter via psp and responsible complaint person (rcp).This case was upgraded due to the serious event of blood glucose increased.The previous non-serious event of blood glucose increased was upgraded to serious due to hospitalization.Added the non-serious event of drug dose omission.The suspect device was updated from humapen unknown to humapen ergo ii.Added ethnicity of the patient, eu/ca fields, hospitalization details, approximate start date of the humapen ergo ii and laboratory data.Updated description as reported of the event of memory impairment and the narrative with the new information.Edit 08jul2019: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Edit 09-jul-2019: upon review for device submission suspect device was updated from humapen ergo ii to humapen unknown.Narrative and fields were updated accordingly.Update 22jul2019: additional information received on 22jul2019 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields/ european and canadian (eu/ca) device information, and device return status to not returned to manufacturer for pc 4787282 relating to unknown lot of humapen unknown device.Corresponding fields and narrative updated accordingly.Edit 07aug2019: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Edit 21aug2019: upon internal review, updated the additional manufacturer narrative on the device medwatch information.No additional information added.
 
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Brand Name
HUMAPEN, UNKNOWN DEVICE
Type of Device
FOR TREATMENT PURPOSES
Manufacturer (Section D)
ELI LILLY AND COMPANY
lilly corporate center
indianapolis IN 46285
MDR Report Key8782001
MDR Text Key150747827
Report Number1819470-2019-00123
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 08/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received07/22/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Weight75
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