BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2810348 · Received October 31, 2012

    Report

    Report Number
    2531779-2012-12975
    Event Type
    Injury
    Date Received
    October 31, 2012
    Report Date
    October 9, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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

    ON (B)(6) 2012, THE PATIENT CONTACTED ANIMAS TO REPORT THAT THE SUBJECT PUMP KEPT LOOSING POWER WITHOUT WARNING. THE PATIENT STATED, SHE WOULD ONLY BECOME AWARE OF THE POWER ISSUE WHEN SHE WOULD LOOK AT PUMP AND NOTICE IT WAS ON THE VERIFY SCREEN. IT IS NOT KNOWN WHEN THE ALLEGED POWER ISSUE STARTED; HOWEVER, THE PATIENT REPORTED THAT APPROXIMATELY 1 MONTH PRIOR TO CONTACTING ANIMAS SHE WAS TREATED IN THE ER FOR A HIGH BLOOD GLUCOSE EXCURSION AS A RESULT OF THE INTERMITTENT POWER ISSUE. THE PATIENT REPORTED THAT ON AN UNSPECIFIED DATE THE PUMP POWERED OFF WITHOUT WARNING. THE PATIENT STATED SHE DIDN'T REALIZE THE PUMP HAD LOST POWER. THE PATIENT STATED SHE DEVELOPED SYMPTOMS OF FEELING TIRED, CONFUSED AND THIRSTY AND HER BLOOD GLUCOSE WAS "626 MG/DL". THE PATIENT REPORTED SHE WENT TO THE ER WHERE SHE WAS TREATED WITH INSULIN INJECTION AND WAS RELEASED FROM THE ER 5 HOURS LATER WITH A BLOOD GLUCOSE OF 123 MG/DL. AT THE TIME OF TROUBLESHOOTING, THE PATIENT DENIED ANY VISIBLE DAMAGE TO THE PUMP'S BATTERY COMPARTMENT, BUT DID CONFIRM THAT THE BATTERY CAP'S YELLOW O-RING WAS VISIBLE. CUSTOMER SUPPORT NOTED THAT THE PATIENT HAD NOT REPLACED THE PUMP'S BATTERY CAP AS RECOMMENDED IN THE INSTRUCTIONS FOR USE. THIS COMPLAINT IS BEING REPORTED BECAUSE, THE PATIENT DEVELOPED SIGNS/SYMPTOM SUGGESTIVE OF HYPERGLYCEMIA AND REQUIRED MEDICAL INTERVENTION FROM AN HCP AFTER THE ALLEGED METER POWER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| L| R