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U.S. Department of Health and Human Services

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

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ELI LILLY AND COMPANY HUMAPEN SAVVIO 3ML (GRAY) FOR TREATMENT PURPOSES Back to Search Results
Model Number MS9699
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problems Fatigue (1849); Hyperglycemia (1905); Hypoglycemia (1912); Overdose (1988); No Code Available (3191)
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 solicited case reported by a consumer via a patient support program (psp), concerned a (b)(6) years-old male patient of unknown ethnicity. Medical history included diabetes (since 1994). Concomitant medications were not provided. The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) (humulin 30/70, cartridge), via reusable pen device (humapen savvio gray) which was started sometime in 2017 (for 3 years), at an unknown dose and frequency, subcutaneously, for diabetes, beginning approximately sometime in 2008. On (b)(6) 2020, while on human insulin 70/30 treatment, his humapen savvio gray got impaired and it did not release medication and he was changing the needle with every cartridge (considered as an improper use). On (b)(6) 2020, his humapen savvio gray did not work (pc number: (b)(6) and lot number: 1308v07) and added that his physician also performed troubleshooting on (b)(6) 2020 and confirmed that the pen got impaired and he had to exchange it. And, since malfunction, he suffered from high blood glucose level and became more than 300 mg/dl (reference range not provided) and his physician felt like as if he was not taking his medication (missed doses). Approximately sometime in 2014, he started to suffer from diabetic foot. He was using insulin syringe (not mentioned since when) and since then his blood glucose became normal (values not provided). Since malfunction, he had fatigue using insulin syringe but he added that it felt better when he takes the insulin. On unknown dates, he had suffered from low blood glucose level coma several times but never was been hospitalized as sometimes (as reported), but that last time this happened was when he took his insulin dose with syringe after this humapen savvio gray issue, as he might take overdose by mistake and his blood glucose reached 50 mg/dl (normal reference range not provided) and the coma lasted every time for one hour. Information regarding additional corrective treatment was not provided. He had not recovered from the events of fatigue and diabetic foot while had fully recovered from the remaining events. Human insulin 70/30 treatment was continued. The patient was the operator of the humapen savvio gray device and his training status was not provided. The humapen savvio gray device general model duration of use was not provided and suspect humapen savvio gray device model duration of use was approximately three years. The action taken with humapen savvio gray device was not provided and its return was expected. The reporting consumer did not relate the event of high blood glucose while did not provide any relatedness for the remaining events with human insulin 70/30 treatment. The reporting consumer did not provide any relatedness for the events of low blood glucose and diabetic foot while related the remaining events with its humapen savvio gray device. Edit 23jul2020: updated medwatch and european and (b)(6) fields for expedited device reporting. No new information added. Edit 23-jul-2020: upon review of information received on 18-jul-2020, device coding updated to humapen savvio gray (previously: humapen savvio graphite) as per cire report information and updated narrative with correct device. No other changes were done.
 
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Brand NameHUMAPEN SAVVIO 3ML (GRAY)
Type of DeviceFOR TREATMENT PURPOSES
Manufacturer (Section D)
ELI LILLY AND COMPANY
lilly corporate center
indianapolis, in
Manufacturer (Section G)
PHILLIPS-MEDISIZE CORPORATION
415 red cedar street
medical device manufacturing
menomonie, wi
Manufacturer Contact
chris davis
lilly corporate center
indianapolis, in 
4334585
MDR Report Key10332284
MDR Text Key208971186
Report Number1819470-2020-00093
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 08/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMS9699
Device Lot Number1308V07
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/12/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/31/2013
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: 07/28/2020 Patient Sequence Number: 1
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