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U.S. Department of Health and Human Services

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

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ELI LILLY AND COMPANY HUMAPEN SAVVIO 3ML (PINK) FOR TREATMENT PURPOSES Back to Search Results
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.
 
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Brand NameHUMAPEN SAVVIO 3ML (PINK)
Type of DeviceFOR TREATMENT PURPOSES
Manufacturer (Section D)
ELI LILLY AND COMPANY
lilly corporate center
indianapolis IN 46285
Manufacturer (Section G)
TECH GROUP NORTH AMERICA INC. DBA WEST
640 south rockford drive
tempe AZ 85281
Manufacturer Contact
chris davis
lilly corporate center
indianapolis, IN 46285
3174334585
MDR Report Key9451075
MDR Text Key188586233
Report Number1819470-2019-00220
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K160668
Number of Events Reported1
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 Received12/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMS9697
Device Lot Number1309V06
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/12/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/30/2013
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: 12/11/2019 Patient Sequence Number: 1
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