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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 Problems Mechanical Problem (1384); Use of Device Problem (1670)
Patient Problem Hypoglycemia (1912)
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
Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This spontaneous case, reported by a consumer who contacted the company to report adverse events and product complaint (pc), concerned a (b)(6) years-old female patient of unknown origin.Medical history included lumbar disc herniation.Drug adverse reaction history, family drug adverse reaction and concomitant medication were not provided.The patient received insulin lispro protamine suspension 50%/insulin lispro 50% (rdna origin) injections (humalog 50) from cartridges via re-usable device (humapen unknown device), 26 units in the morning and 24 units in the evening, subcutaneously for the treatment of diabetes mellitus; start date was 2001 or 2011 (as reported).Dosage regimen was not provided.On an unknown date after starting insulin lispro protamine suspension 50%/insulin lispro 50% therapy, she had the situation of unstable blood glucose (values were not provided).Her waist was not good which required hospitalization (hospitalization time was not provided).Reportedly, she had issues with working of her humapen unknown device (specific condition was unknown) (pc 5520355/lot number unknown).Also during insulin lispro protamine suspension 50%/insulin lispro 50% her preexistent lumbar disc herniation required hospitalization (possible worsening); she was admitted on (b)(6) 2021.Further details regarding hospitalization were not specified.She was discharged on (b)(6) 2021, and after discharge his insulin lispro protamine suspension 50%/insulin lispro 50% dose was changed to 18 units in the morning and 18 units in the evening.She also felt weak and hungry, it was deemed she had hypoglycemia (values were two to four folds, below); this event was deemed to be serious due to its medical significance.She received glucose and improved.Information regarding further corrective treatment or outcome for the events was not provided.Insulin lispro protamine suspension 50%/insulin lispro 50% treatment was continued.The operator of the humapen unknown device and his/her training status were not provided.The humapen unknown device model duration of use and the suspect humapen unknown device duration of use were not provided.The action taken with the suspect humapen unknown device and its return were not provided.The reporting consumer did not provide a relatedness assessment between the events and insulin lispro protamine suspension 50%/insulin lispro 50%therapy or humapen unknown device.Update 22-apr-2021: additional information was received on 13-apr-2021 from the initial reporter.Added medical history of disc herniation and laboratory data.Added information regarding start date, dose regimens, and updated the action taken with insulin lispro protamine suspension 50%/insulin lispro 50%.Added serious events of lumbar disc herniation and hypoglycemia.Updated narrative accordingly.Edit 23-apr-2021: updated medwatch and european and (b)(6)(eu/(b)(6)) fields for expedited device reporting.No new information added.Edit 26-apr-2021: updated medwatch field from (b)(4).
 
Event Description
Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This spontaneous case, reported by a consumer who contacted the company to report adverse events and product complaint (pc), concerned a 72-years-old female patient of unknown origin.Medical history included lumbar disc herniation.Drug adverse reaction history, family drug adverse reaction and concomitant medication were not provided.The patient received insulin lispro protamine suspension 50%/insulin lispro 50% (rdna origin) injections (humalog 50) from cartridges via re-usable device (humapen unknown device), (b)(4) units in the morning and (b)(4) units in the evening, subcutaneously for the treatment of diabetes mellitus; start date was 2001 or 2011 (as reported).Dosage regimen was not provided.On an unknown date after starting insulin lispro protamine suspension 50%/insulin lispro 50% therapy, she had the situation of unstable blood glucose (values were not provided).Her waist was not good which required hospitalization (hospitalization time was not provided).Reportedly, she had issues with working of her humapen unknown device (specific condition was unknown) (pc (b)(4)/ lot number unknown).Also during insulin lispro protamine suspension 50%/insulin lispro 50% her preexistent lumbar disc herniation required hospitalization (possible worsening); she was admitted on (b)(6) 2021.Further details regarding hospitalization were not specified.She was discharged on (b)(6) 2021 and after discharge his insulin lispro protamine suspension 50%/insulin lispro 50% dose was changed to (b)(4) units in the morning and (b)(4) units in the evening.She also felt weak and hungry, it was deemed she had hypoglycemia (values were two to four folds, below); this event was deemed to be serious due to its medical significance.She received glucose and improved.Information regarding further corrective treatment or outcome for the events was not provided.Insulin lispro protamine suspension 50%/insulin lispro 50% treatment was continued.The operator of the humapen unknown device and his/her training status were not provided.The humapen unknown device model duration of use and the suspect humapen unknown device duration of use were not provided.The action taken with the suspect humapen unknown device was not provided.The suspect humapen unknown device associated with product complaint (b)(4) was not returned to the manufacturer.The reporting consumer did not provide a relatedness assessment between the events and insulin lispro protamine suspension 50%/insulin lispro 50%therapy or humapen unknown device.Update 22-apr-2021: additional information was received on 13-apr-2021 from the initial reporter.Added medical history of disc herniation and laboratory data.Added information regarding start date, dose regimens, and updated the action taken with insulin lispro protamine suspension 50%/insulin lispro 50%.Added serious events of lumbar disc herniation and hypoglycemia.Updated narrative accordingly.Edit 23apr2021: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Edit 26apr2021: updated medwatch field from 4607 hospitalization to 4614 medically significant for the serious event of hypoglycemia.Update 29apr2021: additional information received on 27apr2021 from global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields with device information and the european and canadian (eu/ca) device information for the humapen unknown device associated with product complaint 5520355 which was not was not returned to the manufacturer.Corresponding fields and narrative 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 29apr2021 in the b.5.Field.No further follow-up is planned.Evaluation summary: a female patient reported that her humapen (unspecified device type) had an unspecified malfunction.She experienced hypoglycemia.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 with high probability.There is no evidence of improper use or storage.
 
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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 Key11726766
MDR Text Key262973176
Report Number1819470-2021-00063
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 05/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2021
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
Date Manufacturer Received04/27/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age72 YR
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