BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3874473 · Received June 16, 2014

    Report

    Report Number
    2531779-2014-17103
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Report Date
    June 12, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/21/2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP¿S BLACK BOX HISTORY SHOWED THAT THE PUMP WAS MANUALLY SUSPENDED ON (B)(6) 2014 AT 05:12 FOLLOWED BY AN UNEXPLAINED POWER REBOOT. THE NEXT PRIME WAS RECORDED ON (B)(6) 2014 AT 05:11. DURING TESTING, THE PUMP POWERED ON WITH AUDIO TONES, VIBRATIONS, AND A FULLY FUNCTIONAL DISPLAY SCREEN. THE PUMP WAS EXERCISED FOR 24 HOURS ON A 1 UNIT PER HOUR BASAL RATE AND THE TOTAL DAILY DOSAGE WAS CORRECTLY REFLECTED IN THE PUMP HISTORY AS 24.0 UNITS. A DELIVERY ACCURACY TEST WAS SUCCESSFULLY COMPLETED. THE PUMP WAS FOUND TO BE DELIVERING ACCURATELY AND WITHIN THE REQUIRED SPECIFICATIONS. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED THAT THE DISPLAY SCREEN WAS DISCOLORED. THE COMPLAINT OF THE BASAL HISTORY TOTALS NOT MATCHING THE PROGRAMMED BASAL RATE WAS NOT ABLE TO BE DUPLICATED DURING INVESTIGATION. 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 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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A HISTORY/SETTINGS (HISTORY/SETTINGS ISSUE) ISSUE. THE REPORTER ALLEGED THAT THE BASAL HISTORY TOTALS DO NOT MATCH THE PROGRAMMED BASAL RATE. THE INDICATED BLOOD GLUCOSE (BG) LEVEL GREATER THAN 250 MG/DL BUT LESS THAN 500 MG/DL WITH NO KETONES WAS NOT INDICATIVE OF A SERIOUS INJURY AND DOES NOT MEET THE ANIMAS CRITERIA OF AN ADVERSE EVENT. 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
    352598 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR