BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4171725 · Received October 14, 2014

    Report

    Report Number
    2531779-2014-29221
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Report Date
    October 1, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE BLACK BOX RECORDED AN EMPTY CARTRIDGE ALARM. THE ALARM WAS ACKNOWLEDGED WITH A BUTTON PRESS, FOLLOWED BY A LOSS OF PRIME ALARM. THE PUMP WAS THEN PRIMED FOLLOWING THE LOSS OF PRIME. THERE WERE NO PRIME ISSUES FOUND DURING INVESTIGATION. A FORCE SENSOR CALIBRATION READING WAS WITHIN SPECIFICATION. NO DEFECTS WERE FOUND TO THE PUMP. 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

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING THAT THE PUMP PRIMED ON IT'S OWN IN THE MIDDLE OF THE NIGHT. THE REPORTER STATED THAT THE PATIENT DOES NOT REMEMBER PUSHING ANY BUTTONS OR THAT THE PUMP EMITTED A REPLACE CARTRIDGE ALARM. 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
    650300 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR