BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2943928 · Received February 5, 2013

    Report

    Report Number
    2531779-2013-01481
    Event Type
    Injury
    Date Received
    February 5, 2013
    Report Date
    January 9, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE 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. USER ERROR CANNOT BE DISCOUNTED, AS THE USER WAS AWARE THAT THE BATTERY CAP WAS NOT TIGHTENING.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS AND ALLEGED THAT PUMP LOST POWER LAST ON DURING THE NIGHT OF (B)(6) 2013, AND THAT POWER LOSS HAD OCCURRED DURING THE PREVIOUS TWO WEEKS PRIOR ALSO ABOUT 3-4 TIMES. SHE REPORTS THAT DURING THE NIGHT THE PUMP HAS TURNED OFF AND SHE WOKE UP WITH POWER OFF, NO AUDIBLE SOUNDS OR DISPLAY VISIBLE. THE FIRST TIME SHE PUT TOOK BATTERY OUT AND PUT SAME AA LITHIUM BACK IN AND PUMP POWERED ON, NEXT 3 TIMES SHE CHANGED BATTERY WHEN THAT HAPPENED AND PUMP POWERED BACK ON. DURING TROUBLESHOOTING CUSTOMER TECHNICAL SUPPORT (CTS) NOTED THAT THE BATTERY CAP WAS CHANGED WITHIN 4-6 MONTHS BUT THAT BATTERY HAD BEEN PURCHASE LONG BEFORE AND WAS OUT OF WARRANTY, AND THE BATTERY CAP THREADS ARE STRIPPED. SHE DOES NOT HAVE NEW BATTERY CAP WITH HER TO CHANGE OUT. THE REPORTER ADMITS THAT SHE HAS NOTICED OVER PAST WEEK THAT BATTERY CAP IS NOT TIGHTENING ALL THE WAY. STATES SHE CHECKED BLOOD GLUCOSE (BG) ONE TIME AND METER SAID "HIGH". THE OTHER 3 TIMES THE POWER WAS OFF HER BG WAS IN 300MG/DL'S. SHE FELT MILD NAUSEA AND GROGGY EACH TIME, TOOK INJECTIONS WITH SYRINGE WHICH BROUGHT IT BACK DOWN IN RANGE OF 100MG/DL. CTS ADVISED THE REPORTER TO GO TO BACK-UP PLAN UNTIL SHE CAN GET NEW BATTERY CAP. SHE IS AWARE OF CHANGING BATTERY CAP ROUTINELY EVERY 6 MONTHS. THE PATIENT BG IS 124MG/DL AT TIME OF CALL, AND SHE GOING TO BE USING A BACK-UP PLAN. THIS COMPLIANT IS BEING REPORTED DUE TO THE ALLEGATION THAT A PATIENT ON PUMP THERAPY EXPERIENCED HYPERGLYCEMIA. USE ERROR CANNOT BE DISCOUNTED AS A CONTRIBUTORY FACTOR, AS THE PATIENT CONTINUED TO USE THE PUMP AFTER SHE WAS AWARE THAT THE BATTERY CAP WAS NOT TIGHTENING, AND THE USER GUIDE INSTRUCTS THAT THE BATTERY CAP CONNECTION MUST REMAIN INTACT TO AVOID POWER INTERRUPTION TO THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47948 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION OTP GLUCOSE MGMT SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Life Threatening