BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4140337 · Received October 3, 2014

    Report

    Report Number
    2531779-2014-28321
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Report Date
    September 22, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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 11/25/2014 WITH THE FOLLOWING FINDINGS: THE BLACK BOX SHOWED NO ACTIVITY OUTSIDE OF NORMAL USE. THE RETURNED BATTERY CAP AND CARTRIDGE CAP WERE USED TO COMPLETE THE INVESTIGATION. THE PUMP EZ-PRIME STEPS WERE PERFORMED CORRECTLY. NO ALARMS OCCURRED DURING THE INVESTIGATION; THE PRODUCT PERFORMED WITHIN SPECIFICATION. PRODUCT ANALYSIS WAS UNABLE TO DUPLICATE THE INITIAL COMPLAINT OF A REWIND ISSUE. THE PUMP COVER WAS REMOVED FOR FURTHER INVESTIGATION AND NO INTERMITTENT CONDITION WAS FOUND TO THE MOTOR CIRCUIT AND NO DEBRIS WAS FOUND TO THE CARTRIDGE COMPARTMENT.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A MOTOR (REWIND ISSUE) ISSUE. THE REPORTER STATED THAT THE MOTOR REWIND WAS SLOW. 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
    619134 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR