BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4013041 · Received August 15, 2014

    Report

    Report Number
    2531779-2014-23541
    Event Type
    Malfunction
    Date Received
    August 15, 2014
    Report Date
    August 8, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/01/2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP¿S BLACK BOX HISTORY SHOWED THAT THE LAST BOLUS WAS ON (B)(6) 2014 AND THE LAST BASAL DELIVERY WAS ON (B)(6) 2014. ON (B)(6) 2014 AN UNEXPLAINED LOSS OF PRIME OCCURRED AND DELIVERIES WERE NEVER RESUMED. THE PUMP¿S TOTAL DAILY DOSAGE¿S ADDED UP CORRECTLY AND REFLECTED THE USERS PROGRAMMED BASAL RATE. DURING TESTING, THE PUMP WAS EXERCISED FOR 24 HOURS ON A 1 UNIT PER HOUR BASAL RATE. AT THE END OF THE DURATION TEST THE TOTAL DAILY DOSAGE BASAL HISTORY WAS CORRECTLY RECORDED AS 24 UNITS. THE PUMP PASSED A DELIVERY ACCURACY TEST AND WAS FOUND TO BE OPERATING WITHIN THE REQUIRED SPECIFICATIONS AND DELIVERING ACCURATELY. THE COMPLAINT THAT THE PUMP WAS DELIVERING INSULIN INACCURATELY WAS NOT ABLE TO BE DUPLICATED DURING INVESTIGATION. NO DEFECTS WERE FOUND.

    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 PUMP WAS DELIVERING INSULIN INACCURATELY. IT WAS NOTED THAT THE BASAL HISTORY DID NOT MATCH THE ACTIVE BASAL PROGRAM. THE INDICATED BLOOD GLUCOSE (BG) LEVEL GREATER THAN 250 MG/DL BUT LESS THAN 500 MG/DL WITH NO REPORTED SYMPTOMS 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
    489576 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR