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U.S. Department of Health and Human Services

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

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ELI LILLY AND COMPANY HUMAPEN SAVVIO 3ML (GRAPHITE) FOR TREATMENT PURPOSES Back to Search Results
Model Number MS9698
Device Problems Improper or Incorrect Procedure or Method (2017); Physical Resistance/Sticking (4012)
Patient Problems Abdominal Pain (1685); Hyperglycemia (1905); Pain (1994); Numbness (2415); Weight Changes (2607)
Event Type  malfunction  
Manufacturer Narrative
Reportable malfunction/incident identified. Investigation in progress. A follow-up report will be submitted when the final evaluation is completed as necessary.
 
Event Description
Lilly case id: (b)(6). This report is associated with product compliant: (b)(4). This solicited case, reported by a consumer via a patient support program (psp), concerned an approximately (b)(6) year old female patient of unknown origin. Medical history and concomitant medications were not provided. The patient received human insulin isophane suspension 70%/ human insulin 30% (rdna origin) injections (humulin 70/30) via reusable humapen savvio (graphite) pen. Dosage regimen, route of administration, indication for use and start date were not reported. Since unknown date, patient was not taking her human insulin 70/30, she frequently skipped her dose and only took it when she was very tired. Additionally, the blood glucose level of her mother was always in range of 500mg/dl. She was eating the wrong diet, loose a lot of weight (current weight (b)(6) kg), experienced abdomen pain and she was also suffering from leg and right hand pain and numbness. On unknown date, her humapen savvio (graphite) pen was put in the freezer and when it was taken out the dose knob became very stiff, it hardly rotated, it was very difficult to press on the dose knob (lot 1305v06/product complaint (b)(4)). Information regarding corrective treatment, outcome for the events and human insulin isophane suspension 70/30 treatment status was not provided. The user of the humapen savvio graphite was unknown and his/her training status was not provided. The humapen savvio graphite model duration of use and the suspect humapen savvio graphite duration of use were not provided. The humapen savvio graphite was returned to the manufacturer on 17jul2019. The reporting consumer did not provide an opinion of relatedness between the events and human insulin isophane suspension 70/30 or to the humapen savvio. Update 13aug2019: additional information received on 17jul2019 from global product complaint database. Processed (b)(4) accordingly. Updated the medwatch fields/ european and canadian (eu/ca) device information and the humapen savvio (graphite) device to malfunction yes/cirm for product complaint (b)(4) and preliminary comments, priority changed as a result. Added date of return to the manufacturer. Corresponding fields and narrative updated accordingly.
 
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Brand NameHUMAPEN SAVVIO 3ML (GRAPHITE)
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 Key8894238
MDR Text Key196267881
Report Number1819470-2019-00154
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 09/18/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/14/2019
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberMS9698
Device Lot Number1305V06
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer07/17/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/22/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/31/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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