MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN SAVVIO 3ML (PINK); FOR TREATMENT PURPOSES

Model Number MS9697

Device Problem Physical Resistance/Sticking (4012)

Patient Problems Hyperglycemia (1905); Visual Impairment (2138)

Event Date 01/31/2017

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 compliant: (b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerned a (b)(6)-year-old male patient of unknown origin.Medical history was not provided.Concomitant medications included candesartan cilexetil for hypertension, fenofibrate for high blood-triglyceride level, unspecified vitamin d and thioctic acid for neuroprotection and glimepiride and unspecified vitamin b12, both for unknown indications.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) injection (humulin 70/30), via a reusable pen humapen (unknown) subcutaneously, for the treatment of diabetes mellitus, beginning on an unknown date (reported as more than 10-12 years ago).Dosage regimen was not provided.He also received pioglitazone (diabetonorm, unknown manufacturer), to ease the human insulin initiation for the treatment of diabetes mellitus, beginning approximately in 2015 or 2016.Dosage regimen and route of administration were not provided.In 2015 or 2016, he started receiving human insulin isophane suspension 70%/human insulin 30% via a reusable pen humapen savvio pink.In 2015 or 2016, he had excess abdominal fat due to which he stopped taking pioglitazone.Sometime in 2017, his blood glucose (bg) level control was poor which led to leaching in the retina of the eye associated with weak vision.He was prescribed unspecified ocular injections.The events of high bg and retinal leaching were considered as serious due to their medical significance.Reportedly, it occurred as a result of uncontrolled diet.Approximately on (b)(6) 2019, the screw of humapen savvio pink got stuck leading to difficulty releasing the insulin (lot number: 1309v06, product complaint number: unknown) and since then he was administering human insulin isophane suspension 70%/human insulin 30% by syringe.Approximately on (b)(6) 2019, his blood glucose (bg) level went high around 150-160 mg/dl especially in the morning (normal range: 130 mg/dl).He had not recovered from the events.Information regarding corrective treatment of remaining events was unknown.It was unknown if pioglitazone would be resumed or not.Status of human insulin isophane suspension 70%/human insulin 30% treatment was continued.The patient was the operator of humapen savvio pink and his training status was not provided.The general humapen savvio pink duration of use was approximately four years (started sometime in 2015) and suspect humapen savvio pink model duration was approximately two years.The humapen savvio pink was continued and its return was expected.The initial reporting consumer did not relate the events of high bg (second episode), retinal leaching and excess abdominal fat and did not provide relatedness assessment of remaining event with human insulin isophane suspension 70%/human insulin 30% treatment.The initial reporting consumer did not provide an opinion of relatedness between the events and pioglitazone treatment.The initial reporting consumer related the event of high bg (second episode) with the product complaint associated with humapen savvio pink, did not relate retinal leaching and did not provide relatedness for remaining events with humapen savvio pink.Edit 09dec2019: updated medwatch fields for expedited device reporting.No new information added.

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 dated 13dec2019 in the b.5.Field.No further follow-up is planned.Evaluation summary: a male patient reported a serious adverse event of abnormal blood glucose in 2017 (exact date unknown).Approximately on (b)(6) 2019, the screw of his humapen savvio device got stuck, leading to difficulty releasing the insulin.He experienced a non-serious adverse event of increased blood glucose.The device was not returned to the manufacturer for investigation (batch 1309v06, manufactured september 2013).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.A complaint history review of the batch did not identify any atypical findings with respect to pen jammed.All humapen savvio 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), concerned a 62-year-old male patient of unknown origin.Medical history was not provided.Concomitant medications included candesartan cilexetil for hypertension, fenofibrate for high blood-triglyceride level, unspecified vitamin d and thioctic acid for neuroprotection and glimepiride and unspecified vitamin b12, both for unknown indications.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) injection (humulin 70/30), via a reusable pen humapen (unknown) subcutaneously, for the treatment of diabetes mellitus, beginning on an unknown date (reported as more than 10-12 years ago).Dosage regimen was not provided.He also received pioglitazone (diabetonorm, unknown manufacturer), to ease the human insulin initiation for the treatment of diabetes mellitus, beginning approximately in 2015 or 2016.Dosage regimen and route of administration were not provided.In 2015 or 2016, he started receiving human insulin isophane suspension 70%/human insulin 30% via a reusable pen humapen savvio (pink), lot number 1309v06.In 2015 or 2016, he had excess abdominal fat due to which he stopped taking pioglitazone.Sometime in 2017, his blood glucose (bg) level control was poor which led to leaching in the retina of the eye associated with weak vision.He was prescribed unspecified ocular injections.The events of high bg and retinal leaching were considered as serious due to their medical significance.Reportedly, it occurred as a result of uncontrolled diet.Approximately on (b)(6) 2019, the screw of humapen savvio (pink) got stuck leading to difficulty releasing the insulin (product complaint number (b)(4)/lot number 1309v06).Since then he was administering human insulin isophane suspension 70%/human insulin 30% by syringe.Approximately on (b)(6) 2019, his blood glucose (bg) level went high around 150-160 mg/dl especially in the morning (normal range: 130 mg/dl).He had not recovered from the events.Information regarding corrective treatment of remaining events was unknown.It was unknown if pioglitazone would be resumed or not.Status of human insulin isophane suspension 70%/human insulin 30% treatment was continued.The patient was the operator of humapen savvio (pink) and his training status was not provided.The general humapen savvio (pink) duration of use and suspect device duration of use was approximately four years (started sometime in 2015).The suspect humapen savvio (pink) device associated with product complaint (b)(4) was not returned to the manufacturer.The initial reporting consumer did not relate the events of high bg (second episode), retinal leaching and excess abdominal fat and did not provide relatedness assessment of remaining event with human insulin isophane suspension 70%/human insulin 30% treatment.The initial reporting consumer did not provide an opinion of relatedness between the events and pioglitazone treatment.The initial reporting consumer related the event of high bg (second episode) with the product complaint associated with humapen savvio pink, did not relate retinal leaching and did not provide relatedness for remaining events with humapen savvio (pink).Edit 09dec2019: updated medwatch fields for expedited device reporting.No new information added.Update 13dec2019: additional information received on 12dec2019 from the 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.Added date of manufacturer for the suspect humapen savio (pink) associated with product complaint (b)(4), which was not returned to the manufacturer.Corresponding fields and narrative updated accordingly.Upon review, updated suspect device age from 2 years to 4 years.

• Brand Name: HUMAPEN SAVVIO 3ML (PINK)
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• MDR Report Key: 9451075
• MDR Text Key: 188586233
• Report Number: 1819470-2019-00220
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K160668
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MS9697
• Device Lot Number: 1309V06
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR