BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3062748 · Received April 17, 2013

    Report

    Report Number
    2531779-2013-04394
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Report Date
    March 19, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION FOLLOW-UP #1 SUBMITTED (B)(4) 2013: THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING RESULTS:THE POWER COMPLAINT WAS VERIFIED IN THE HISTORY BUT COULD NOT BE DUPLICATED DURING THE INVESTIGATION. POWER ON RESETS OBSERVED IN THE BLACK BOX. NO DAMAGE WAS FOUND TO THE RETURNED BATTERY CAP OR THE BATTERY COMPARTMENT. NO ISSUES WHEN ATTACHING THE RETURNED BATTERY CAP TO THE PUMP; THE YELLOW O RING IS NOT VISIBLE. NO FUNCTION DEFECTS WERE OBSERVED WITH THE BATTERY CAP, THE HIEGHT AND WIDTH OF WHICH WERE WITHIN SPECIFICATIONS. NO POWER INTERRUPTIONS WERE DUPLICATED WHEN THE PUMP WAS EXERCISED FOR 24 HOURS WITH THE RETURNED BATTERY CAP.TO FURTHER INVESTIGATE THE PUMP COVER WAS REMOVED; NO EVIDENCE OF INTERNAL MOISTURE OR DAMAGE TO THE POWER CIRCUIT OR BATTERY FLEX WAS FOUND. 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) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (INTERMITTENT POWER) ISSUE. THE REPORTER STATED THAT THE PUMP HAD LOST POWER. 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
    166260 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR