BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2143437 · Received June 29, 2011

    Report

    Report Number
    2531779-2011-04555
    Event Type
    Injury
    Date Received
    June 29, 2011
    Date of Event
    May 31, 2011
    Report Date
    May 31, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE REPORTER, THE PATIENT'S DAUGHTER, REPORTED THAT ON (B)(6) 2011 THE PATIENT NOTED A LOSS OF PRIME ON THE INSULIN PUMP, AND AFTERWARDS EXPERIENCED "AN INSULIN REACTION". THE PATIENT'S SPEECH WAS SLURRED AND SHE EXPERIENCED CONFUSION. THE PATIENT DID NOT TEST HER BLOOD GLUCOSE LEVEL AT THAT TIME. THE PATIENT ADMINISTERED SELF-TREATMENT BY CONSUMING A CANDY BAR; HER SUBSEQUENT BLOOD GLUCOSE READING WAS 67 MG/DL AT 6:57 PM. SHE DID NOT SEEK ANY MEDICAL ATTENTION. TROUBLESHOOTING REVEALED THAT THE PATIENT HAD REMAINED CONNECTED TO THE PUMP WHEN SHE ADDRESSED THE SECOND LOSS OF PRIME ISSUE, WHICH CAN CONTRIBUTE TO OVER-INFUSION OF INSULIN. THE TECHNICAL SUPPORT REPRESENTATIVE ALSO DETERMINED THE BATTERY CAP WAS WORN AND WOULD NOT REMAIN SECURE, AND THAT THE PATIENT HAD NOT REPLACED IT. THE PATIENT'S TECHNIQUE WAS INCORRECT IN THAT SHE PRIMED THE PUMP WHILE IT WAS ATTACHED TO HER BODY AND SHE DID NOT REPLACE THE WORN BATTERY CAP. HOWEVER, AS THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE HYPOGLYCEMIA AFTERWARDS, WHILE USING THE PUMP, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION OTP GLUCOSE MGMT SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Life Threatening