BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3834043 · Received May 27, 2014

    Report

    Report Number
    2531779-2014-14856
    Event Type
    Injury
    Date Received
    May 27, 2014
    Report Date
    May 19, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: DATES IN TOTAL DAILY DOSE HISTORY CHANGE FROM (B)(6) 2014 TO (B)(6) 2014, FROM (B)(6) 2014 TO (B)(6) 2014, FROM (B)(6) 2014 TO (B)(6) 2014 AND FROM (B)(6) 2014 TO (B)(6) 2014. DAILY INSULIN DELIVERY TOTALS APPEAR INCONSISTENT DUE TO TIME/DATE ISSUE. BLACK BOX SHOWS TIME AND DATE RESETTING TO DEFAULT FOLLOWING A POWER ON RESET AT 12:47PM (B)(6) 2014; THE TIME WAS THEN MANUALLY SET TO 1:03AM (B)(6) 2014. PUMP PASSED DELIVERY ACCURACY TEST AND FOUND TO BE DELIVERING WITHIN REQUIRED SPECIFICATIONS. DISPLAY IS DIM; LETTERS HAVE A RED HUE. PUMP TIME AND DATE WAS SET; PUMP EXERCISED FOR 24 HOURS. THE BATTERY WAS REMOVED. PUMP LEFT WITHOUT POWER FOR 6 HOURS; WHEN PUMP POWERED ON IT HAD RETURNED TO DEFAULT TIME AND DATE. PUMP OPENED AND THE INTERNAL BATTERY FOUND TO BE LEAKING. 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) 2014, THE REPORTER CONTACTED ANIMAS AND ALLEGED THE PATIENT HAS HAD BLOOD GLUCOSE (BG) LEVELS OF 30-40 MG/DL AND OVER 300 MG/DL, NO SYMPTOMS PROVIDED. CUSTOMER SUPPORT CONSIDERED THIS TO BE AN INACCURATE DELIVERY ISSUE WITH THE PUMP. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED HYPOGLYCEMIA AND THE PUMP CANNOT BE RULED OUT AS A CAUSE/CONTRIBUTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310610 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Life Threatening