BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4183270 · Received October 17, 2014

    Report

    Report Number
    2531779-2014-29631
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Report Date
    October 6, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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

    PRODUCT ANALYSIS: THE DEVICE WAS RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 12/11/2014 WITH THE FOLLOWING FINDINGS: THE COMPLAINT COULD NOT BE DUPLICATED OR CONFIRMED. REVIEW OF THE PUMP¿S BLACK BOX REVEALED NO ABNORMAL FUNCTION OR ISSUES. THE DELIVERY HISTORY ACCURATELY REFLECTS THE USER PROGRAMMED BASAL RATES AND BOLUS DELIVERIES. THE PUMP SUCCESSFULLY COMPLETED A PRIME SEQUENCE, BOLUS DELIVERIES, AND 24-HOUR EXERCISE TEST WITHOUT ISSUE OR ALARM. THE PUMP PASSED A DELIVERY ACCURACY TEST. ALL DELIVERIES PERFORMED DURING INVESTIGATION WERE ACCURATELY RECORDED IN THE PUMP¿S HISTORY AND BLACK BOX. UNRELATED TO THE COMPLAINT, A BATTERY COMPARTMENT WAS DISCOVERED. A BATTERY CAP WAS NOT RETURNED WITH THE PUMP; A TEST CAP WAS ABLE TO SECURE PROPERLY TO THE PUMP. 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, ALLEGING A HISTORY/SETTINGS (HISTORY/SETTINGS ISSUE) ISSUE. IT WAS REPORTED DURING TROUBLESHOOTING THE PUMP WAS NOT CALCULATING RECOMMENDED BOLUS TOTALS CORRECTLY. THE REPORTER NOTED THAT THE PATIENT¿S BLOOD GLUCOSE WAS BETWEEN 250 AND 499 WITHOUT SIGNS OR SYMPTOMS OF HYPERGLYCEMIA. THE REPORTED HEALTH EVENT DOES NOT QUALIFY AS A SERIOUS INJURY. 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
    661046 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR