BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3032402 · Received April 3, 2013

    Report

    Report Number
    2531779-2013-03463
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Report Date
    March 7, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE BATTERY CAP HAS NOT BEEN RETURNED TO ANIMAS. 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) 2013, THE REPORTER CONTACTED ANIMAS AND ALLEGED THE FOLLOWING: HE WOKE UP THIS MORNING AND THE POWER WAS OFF TO HIS PUMP, BATTERY CAP HAD COME OFF AND APPEARED TO BE BROKEN, THE METAL PLATE FELL OFF AND THREADS WERE STRIPPED. PATIENT NEVER CHANGED BATTERY CAP (ALMOST 2 YEARS OLD) AND HE THINKS HE WAS LYING ON PUMP LAST NIGHT, CAUSING BATTERY CAP TO POP OFF. PATIENT THINKS BATTERY CAP MUST HAVE BEEN CRACKED AND HE DIDN'T NOTICE. HE REPORTS NO CRACKS OR DAMAGE TO BATTERY COMPARTMENT OF PUMP. HE WOKE UP THIS MORNING WITH BG 313 MG/DL, FELT SLUGGISH AND TIRED, BUT DID NOT TEST KETONES. HE IS USING BACK-UP PLAN OF SYRINGES. BG HAS COME DOWN TO 213 MG/DL. CUSTOMER TECHNICAL SUPPORT (CTS) REVIEWED THE RECOMMENDATION TO CHANGE BATTERY CAP ROUTINELY EVERY 6 MONTHS, AND ASSISTED PATIENT IN ORDERING A NEW BATTERY CAP. THE BLOOD GLUCOSE EXCURSION DOES NOT MEET THE CRITERIA FOR AN ADVERSE EVENT. THERE IS NO ALLEGATION OF PUMP MALFUNCTION. THIS CASE IS BEING REPORTED DUE TO THE BATTERY CAP BEING BROKEN AND FALLING OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135819 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR