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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hyperglycemia (1905); Numbness (2415); Coma (2417)
Event Date 06/30/2019
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. This device was associated with a diabetic hyperglycaemic coma in (b)(6) 2019, breath odour in (b)(6) 2019, and blood glucose increased on (b)(6) 2019.
 
Event Description
(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 female patient of unknown origin. Medical history and concomitant medications were not provided. The patient received insulin lispro (rdna origin) injections (humalog 100), from cartridge via a reusable device humapen savvio grey, thrice daily (10 units in morning, at lunch time and at night) subcutaneously for the treatment of diabetes mellitus, beginning approximately on (b)(6) 2018. Approximately in (b)(6) 2019, she experienced a hyperglycemic coma associated with recognized mouth odor due to a heavy meal. In (b)(6) 2019, she was admitted in the hospital for 2-3 hours due to the events. The events were resolved on same day and she was discharged from the hospital. Approximately on (b)(6) 2019, her humapen savvio grey got stucked and was unable to release the insulin dose. She missed two days doses however she thought the doses were successfully taken (product complaint number: (b)(4), lot number: 1311v05). Reportedly, she realized that the doses were missed through the high blood glucose level (600 mg/dl) and abdominal ache and leg numbness associated with cracking sound. The event of blood glucose of 600 mg/dl was considered as serious due to its medical significance. Since an unknown date, she started receiving insulin doses using the insulin syringe. She had not recovered from remaining events. Corrective treatment was not provided. Status of insulin lispro treatment was continued. The operator of humapen savvio grey and his/her training status was not provided. The general humapen savvio grey model duration was not provided. The suspect humapen savvio grey duration was approximately 18 months as it was started approximately on (b)(6) 2018. The status of humapen ergo ii was continued and its return was available. The initial reporting consumer did not relate the events with insulin lispro treatment. The initial reporting consumer did not relate the events of hyperglycemic coma and mouth odor and related the remaining events with humapen savvio grey. Edit 18nov2019: updated medwatch fields for expedited device reporting. No new information added. Edit 21nov2019: updated medwatch fields for expedited device reporting. No new information added.
 
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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 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 Key9368231
MDR Text Key179545736
Report Number1819470-2019-00208
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 Received11/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberMS9699
Device Lot Number1311V05
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 Manufactured11/30/2013
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: 11/25/2019 Patient Sequence Number: 1
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