BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2874596 · Received December 15, 2012

    Report

    Report Number
    2531779-2012-14601
    Event Type
    Malfunction
    Date Received
    December 15, 2012
    Report Date
    December 8, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE PUMP BLACK BOX SHOWED EVIDENCE THAT LOSS OF CARTRIDGE DETECTION HAD OCCURRED WITH WAS DUPLICATED DURING TESTING. DURING TESTING, THE PUMP LOAD STEP FAILED TO DETECT THE CARTRIDGE. DURING INSPECTION OF THE PUMP, MOISTURE WAS OBSERVED BEHIND THE DISPLAY SCREEN. A LEAK TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE LEAKING BEHIND THE DISPLAY SCREEN. THE PUMP WAS OPENED AND MOISTURE DAMAGE WAS FOUND ON THE DISPLAY SCREEN, KEYPAD FLEX, AND FORCE SENSOR PINS.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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 REPORTER CONTACTED ANIMAS, ALLEGING A PRIME (LOAD STEP MALFUNCTION) ISSUE. THE REPORTER INDICATED THAT THE PUMP LOST PRIME AND THEN WHEN TRYING TO REPRIME THE PUMP PRIMED ALL OF THE INSULIN OUT OF THE CARTRIDGE. 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
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR