BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3803241 · Received May 9, 2014

    Report

    Report Number
    2531779-2014-13132
    Event Type
    Injury
    Date Received
    May 9, 2014
    Report Date
    April 11, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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

    FOLLOW-UP #1: DATE OF SUBMISSION 08/05/2014. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE BLACK BOX CONTAINS DATES FROM (B)(6) 2014. BLACK BOX FOR REPORTED ISSUE ON (B)(6) 2014 HAS BEEN OVERWRITTEN. DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED BASAL RATES. THE PUMP PASSED DELIVERY ACCURACY TEST AND FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATIONS. THE DISPLAY IS DIM AND THE LETTERS HAVE A RED HUE. 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. 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

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2014 REPORTING THAT THE PUMP RESET TO DEFAULT SETTINGS. THE PATIENT REPORTED BLOOD GLUCOSE (BG) EXCURSIONS FROM LOW 40 MG/DL RANGE WITH SWEATINESS TO HIGH 300 MG/DL RANGE WITH EXCESS URINATION AND GROUCHINESS RANGE. THIS REPORT IS BEING MADE DUE TO THE BG EXCURSION THE PATIENT EXPERIENCED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281559 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Life Threatening