BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2973875 · Received February 22, 2013

    Report

    Report Number
    2531779-2013-02024
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Report Date
    January 27, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. 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. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW UP #1 SUBMITTED: 04/20/2013 DEVICE EVALUATION: ON INVESTIGATION, THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO CHANGE IN BASAL RATE. THE PUMP DID NOT SUSPEND ON ITS OWN DURING TESTING. NORMAL BOLUS AND AUDIO BOLUS WERE BOTH PERFORMED WITHOUT ISSUES AND SUCCESSFULLY RECORDED IN THE PUMP HISTORY. THE KEYPAD WAS TESTED AND ALL THE KEYPAD BUTTONS WERE NOTED TO BE NORMALLY RESPONSIVE WITH NO HYPERSENSITIVE KEYPAD BUTTONS OBSERVED. THE COMPLAINT WAS NOT DUPLICATED DURING INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A HISTORY/SETTINGS (HISTORY/SETTINGS ISSUE) ISSUE. THE REPORTER INDICATED THAT SINCE RESUMING THE PUMP BLOOD GLUCOSE LEVELS WERE IN THE 300 - 400 MG/DL RANGE AND THE REPORTER INDICATED FEELING AS IF THE PUMP WAS NOT DELIVERING APPROPRIATELY. THE REPORTER CONFIRMED THAT THE SUPPLIES WERE CHANGED OUT APPROPRIATELY, THERE WERE NO NOTED ISSUES WITH AIR BUBBLES OR LEAKING, AND THE SITES WERE ROTATED AVOIDING AREAS OF SCAR TISSUE. THE REPORTER DID INDICATE HAVING INCREASED PAIN RECENTLY. THE PUMP WAS REVIEWED AND THE TOTAL DAILY DOSE HISTORY WAS FOUND TO BE CORRECTLY ADDING UP BUT THE BASAL RATES WERE 5-6 UNITS OFF; THE REPORTER CONFIRMED THAT THERE WERE NO CHANGES IN THE BASAL RATES AND THE PUMP WAS NOT TURNED OFF OR SUSPENDED DURING THE DAY. THE REPORTED BLOOD GLUCOSE DOES NOT MEET ANIMAS CRITERIA FOR AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78053 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR