BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3132779 · Received May 29, 2013

    Report

    Report Number
    2531779-2013-07142
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    April 29, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 08/07/2013-DEVICE EVALUATION: THE CARTRIDGE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/15/2013 WITH THE FOLLOWING FINDINGS:A REVIEW OF THE PUMP¿S HISTORY SHOWED A MANUAL TIME CHANGE FROM 4:38 AM TO 4:40 PM ON 04/28/2013. THE INCONGRUENT BASAL HISTORY ON 04/23/2013 WAS VERIFIED IN THE PUMP¿S HISTORY. A TIMEKEEPING ACCURACY TEST WAS PERFORMED, AND THE PUMP MAINTAINED TIME ACCURATELY DURING THE 5 DAY TEST. THE PUMP WAS THEN POWERED OFF FOR AN HOUR AND THEN WHEN POWERED BACK; THE TIME AND DATE HAD RESET TO FACTORY DEFAULT. THE PUMP WAS OPENED AND THE INTERNAL CLOCK BATTERY ON THE INTERNAL CIRCUIT BOARD WAS FOUND TO BE LEAKING. 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. 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

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013, ALLEGING RECEIVING MORE BASAL INSULIN DELIVERY THAN EXPECTED DUE TO THE PUMP TIME RESET AND THE BASAL RATES WERE RESTARTED WITHOUT USER INTERVENTION. THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING RULED OUT BECAUSE THE ALLEGED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235161 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR