BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2870018 · Received December 12, 2012

    Report

    Report Number
    2531779-2012-14464
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Report Date
    November 14, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP 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. 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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 01/29/2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: ACCORDING THE BLACK BOX, ONE NO CARTRIDGE DETECTED WARNING IS RECORDED ON (B)(4) 2012. THE PUMP IS ABLE TO POWER UP NORMALLY AND PASS "EZ-PRIME" STEPS SUCCESSFULLY. THE FORCE SENSOR CALIBRATION READING WAS TAKEN AND WAS FOUND ABOVE NORMAL SPECIFICATIONS. THE PUMP WAS OPENED, THE OLD TAPE AND THE FORCE SENSOR PINS WERE FOUND INTACT; NO DEFECT WAS FOUND TO THE FORCE SENSOR CIRCUIT. THE FORCE SENSOR RESISTANCE WAS TAKEN AND FOUND WITHIN SPECIFICATIONS. UNABLE TO DUPLICATE RECORDED "163" WARNING.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE REPORTER CONTACTED ANIMAS, ALLEGING A PRIME (LOAD STEP MALFUNCTION) ISSUE. THE PUMP REPORTEDLY DISPENSED INSULIN DURING THE LOAD CARTRIDGE STEP. 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 11 YR