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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 Problems Break (1069); Failure to Deliver (2338); Mechanical Jam (2983)
Patient Problems Hyperglycemia (1905); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
If device is returned, evaluation will be performed to determine if a malfunction has occurred. A follow-up report will be submitted when the final evaluation is completed as necessary.
 
Event Description
Lilly case id: (b)(4). This report is associated with product complaint: (b)(4). This spontaneous case, reported by consumer who contacted the company to report adverse events and a product complaint (pc) with additional information from pharmacist, concerned a female patient of unknown age and ethnicity. Medical history and concomitant medications were not provided. The patient began taking insulin lispro (rdna origin) injections (humalog, 100u/ml) from cartridge via a reusable pen (humapen savvio, pink), subcutaneously, for diabetes mellitus (dm) (dose and frequency were not provided), beginning on an unspecified date. On an unknown date, while being on insulin lispro therapy, she had a circulatory collapse and her blood glucose was out of control (values, units and normal reference range not provided) for which she had been hospitalized on (b)(6) 2020 (reported as during the last weekend). On an unknown date, she noticed that her humapen savvio (pink) device was broken as the injection screw did not come out and the humapen savvio (pink) did not release insulin lispro (pc no. (b)(4), lot no. 1405v02). Further information regarding corrective treatment was not provided. She got recovered from the event of circulatory collapse while the outcome for remaining event was not reported. Status of insulin lispro therapy was not provided. Follow up would not be possible as the reporter denied consent and the treating physician contact details were not provided. The operator of the humapen savvio (pink) and his/her training status was not provided. The general humapen savvio (pink) model duration of use and the suspect humapen savvio (pink) model duration of use were not provided. The action taken with the humapen savvio (pink) was not provided and its return was expected. The reporting consumer and pharmacist did not provide any relatedness assessment for the events with insulin lispro therapy and humapen savvio (pink) device. Update 14-aug-2020: information received on 12-aug-2020 and 14-aug-2020 was combined and processed together. Update 24-aug-2020: additional information was received from pharmacist reporter on 21-aug-2020. Added pharmacist reporter. Updated the suspect drug coding to insulin lispro cartridges, product delivered by device and as reported causality for the event of blood glucose abnormal with the suspect humapen savvio (pink) device. Upon review of the case, updated the indication for use to diabetes mellitus. Updated the causality statement and narrative with new information. Edit 27aug2020: updated medwatch european and (b)(6) 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)
PHILLIPS-MEDISIZE CORPORATION
415 red cedar street
medical device manufacturing
menomonie WI 54751
Manufacturer Contact
chris davis
lilly corporate center
indianapolis, IN 46285
3174334585
MDR Report Key10460463
MDR Text Key213220972
Report Number1819470-2020-00107
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 foreign,health professional
Type of Report Initial,Followup
Report Date 10/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/27/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberMS9697
Device Lot Number1405V02
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/24/2020
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/05/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/31/2014
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: 08/27/2020 Patient Sequence Number: 1
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