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U.S. Department of Health and Human Services

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

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ELI LILLY AND COMPANY HUMAPEN SAVVIO (GRAY) FOR TREATMENT PURPOSES Back to Search Results
Model Number MS9699
Device Problems Device Inoperable (1663); Mechanical Jam (2983)
Patient Problem Hyperglycemia (1905)
Event Date 09/30/2016
Event Type  Injury  
Manufacturer Narrative
Narrative field - new, updated and corrected information is referenced within the update statements. Please refer to update statement dated 21nov2016 in the narrative field. No further follow up is planned.
 
Event Description
(b)(4). This spontaneous case, reported by a consumer who contacted the company to report an adverse event, concerns an (b)(6) female patient. The patient had no medical history. Information regarding concomitant medication was not provided. The patient received human insulin (rdna origin) 30% regular 70% nph (humulin 70n/30r) via reusable pen, three doses daily, reported as 14 iu at lunch and the other two dose values were unknown, subcutaneously, for diabetes, beginning on an unknown date reported as more than 20 years from the time of initial report on 08nov2016. In the end of (b)(6) 2016 the patient bought a pen humapen savvio gray (lot number 1406v06) in order to deliver the human insulin. In (b)(6) 2016, unknown time after beginning human insulin 30% regular 70% nph therapy via humapen savvio gray, the pen stopped to work, it was provided that when the patient pressed down the injection button it was jammed (product complaint number 3822752) and the patient sometimes received the dose and sometimes did not receive it (drug dose omission) and due to that on (b)(6) 2016 her diabetes was very high and reached more than 400 mg/dl (no normal range was provided). On (b)(6) 2016 the patient was hospitalized due to the very high glycemia and she was discharged from hospital on (b)(6) 2016 when she recovered from the blood glucose increased. No information about exams and corrective treatment was provided. It was also reported that the patient always reused the needles, she always performed the calibration procedure and stored the pen and human insulin 30% regular 70% nph cartridge in the refrigerator. Treatment with human insulin 30% regular 70% nph was continued. The patient operated the device and she was trained by a physician. The patient had used the reported device for approximately two months and this device model for unknown time. The device was not returned. The reporting consumer related the event of high glycemia to human insulin 30% regular 70% nph therapy. No other opinion of relatedness was provided. Update 11nov2016: upon review, this case was opened to update the medwatch fields for regulatory reporting. Update 21nov2016: additional information received on 21nov2016 from the global product complaint database added the device specific safety summary; added the device was not returned; updated the medwatch and european and canadian required device reporting elements; and updated the narrative.
 
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Brand NameHUMAPEN SAVVIO (GRAY)
Type of DeviceFOR TREATMENT PURPOSES
Manufacturer (Section D)
ELI LILLY AND COMPANY
lilly corporate center
indianapolis IN 46285
Manufacturer (Section G)
ELI LILLY AND COMPANY
lilly corporate center
indianapolis IN 46285
Manufacturer Contact
caroline rosewell
lilly corporate center
indianapolis, IN 46285
3172764376
MDR Report Key6142416
MDR Text Key61356993
Report Number1819470-2016-00300
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 consumer,foreign
Type of Report Initial
Report Date 11/08/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/02/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMS9699
Device Lot Number1406V06
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/08/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/30/2014
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: 12/02/2016 Patient Sequence Number: 1
Treatment
HUMULIN
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