BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4852283 · Received June 17, 2015

    Report

    Report Number
    2531779-2015-20176
    Event Type
    Malfunction
    Date Received
    June 17, 2015
    Report Date
    June 4, 2015
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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. USE ERROR SHOULD BE CONSIDERED AS TIME WAS INCORRECTLY SET.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/20/2015 WITH THE FOLLOWING FINDINGS: REVIEW OF THE TDD HISTORY SHOWS THE USER SET THE TIME/DATE INCORRECTLY; 2 RECORDS FOR (B)(6) 2015 WERE RECORDED IN THE TDD HISTORY THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECT USER'S PROGRAMMED BASAL RATES. PUMP PASSED DELIVERY ACCURACY TEST AND FOUND TO BE DELIVERING WITHIN REQUIRED RANGE AND DELIVERING ACCURATELY. PUMP WAS EXERCISED FOR 24HRS; NO ALARMS WERE DUPLICATED. THE CONCLUSION OF THE INVESTIGATION WAS USER ERROR. 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) 2015, THE REPORTER CONTACTED ANIMAS AND ALLEGED THAT THE PATIENT HAD A BLOOD GLUCOSE (BG) OF 43 MG/DL WITH SYMPTOMS OF COGNITIVE IMPAIRMENT AND CONFUSION. DURING TROUBLESHOOTING, CUSTOMER SUPPORT FOUND THE PATIENT HAD SET THE TIME IN THE PUMP INCORRECTLY, TIME WAS SET FOR P.M. AS OPPOSED TO A.M. THE PATIENT REQUIRED NO UNUSUAL TREATMENT AND CONTINUES ON PUMP THERAPY. THIS COMPLAINT IS BEING REPORTED AS THE PATIENT EXPERIENCED HYPOGLYCEMIA FOLLOWING THE USE ERROR OF SETTING THE TIME IN THE PUMP INCORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395554 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Life Threatening