BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2901228 · Received January 8, 2013

    Report

    Report Number
    2531779-2013-00342
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Report Date
    December 10, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. DEVICE EVALUATION WAS COMPLETED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: BLACK BOX REVIEW SHOWS NO EVIDENCE OF TIME/DATE RESET TO DEFAULT SETTING AFTER LESS THAN 24 HOURS OF POWER ON RESET. THE PUMP WAS UNABLE TO DETECT THE CARTRIDGE DURING A "LOAD" STEP WAS UNABLE TO RUN THE PUMP FOR 24H AND ADEQUATELY INVESTIGATE REPORTED "TIME/DATE RESET." THE PUMP WAS OPENED AND DISASSEMBLED, BT1 INTERNAL BATTERY WAS FOUND CORRODED AND DEFECTIVE. THE FORCE SENSOR CIRCUIT WAS DISASSEMBLED AND CONTAMINATION WAS FOUND ON THE FORCE SENSOR PLATE. FORCE SENSOR RESISTANCE WAS FOUND OUT OF SPECIFICATION. UNRELATED TO THE COMPLAINT. THE PUMP BOOTS UP SUCCESSFULLY BUT WITH A REDDISH AND FADED DISPLAY: A TEST DISPLAY SCREEN WAS USED FOR THE REST OF INVESTIGATION AND IT WAS FULLY ILLUMINATED. 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.

    Description of Event or Problem · 1

    THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT. THE PUMP WAS RETURNED FOR PRODUCT ANALYSIS INVESTIGATION AND THE EVALUATION REVEALED A CORRODED INTERNAL BATTERY, A FADED DISPLAY SCREEN, AND CONTAMINATION ON THE FORCE SENSOR PLATE. THIS REPORT IS MADE BASED ON THE RESULTS OF AN INVESTIGATION COMPLETED ON (B)(4) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9729 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR