BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3021735 · Received March 26, 2013

    Report

    Report Number
    2531779-2013-03097
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Report Date
    March 5, 2013
    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

    FOLLOW-UP #1 DATE OF SUBMISSION 06/20/2013 DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT POWER ON RESETS WERE OBSERVED IN THE BLACK BOX HISTORY. NO PHYSICAL DAMAGE WAS OBSERVED TO THE RETURNED BATTERY CAP OR BATTERY COMPARTMENT; THE RETURNED BATTERY CAP FASTENS SECURELY AND HOLDS POWER TO THE PUMP. THE BATTERY CAP WIDTH AND HEIGHT MEASUREMENTS ARE ALL WITHIN SPECIFIED RANGE. NO POWER INTERRUPTIONS WERE DUPLICATED WHEN THE PUMP WAS EXERCISED FOR 24 HOURS WITH THE RETURNED BATTERY CAP; THE PUMP WAS STILL DELIVERING AT THE CONCLUSION OF TESTING. THE BLACK BOX SHOWS A TIME AND DATE RESET AFTER POWER ON RESETS. THE PUMP COVER WAS REMOVED; NO INTERNAL MOISTURE DAMAGE OR INTERMITTENT CONNECTIONS WERE OBSERVED. EVALUATION REVEALED THE INTERNAL CLOCK BATTERY ON THE PCB BOARD HAD FAILED. THE PUMP WOULD NOT RETAIN THE USER PROGRAMMED DATE AND TIME SETTINGS UPON REMOVAL OF THE PRIMARY AA BATTERY. WHEN A NEW AA BATTERY IS INSERTED THE PUMP DISPLAYS THE DEFAULT DATE AND TIME WHICH MUST BE MANUALLY CONFIRMED (OR RESET) BY THE USER IN ORDER TO PROCEED. THE POWER COMPLAINT WAS VERIFIED IN THE HISTORY BUT COULD NOT BE DUPLICATED DURING THE INVESTIGATION.

    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) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (INTERMITTENT POWER) ISSUE. THE REPORTER STATED THAT THE PUMP WAS SHUTTING OFF RANDOMLY A FEW TIMES PER DAY. 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
    123421 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR