BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3811690 · Received May 15, 2014

    Report

    Report Number
    2531779-2014-13674
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Report Date
    May 6, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 06/17/2014, DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE BLACK BOX SHOWED AN UNEXPLAINED POWER RESET EVENT ON (B)(4) 2014 AND THAT DELIVERIES WERE NEVER RESUMED. THE LAST BOLUS AND THE LAST BASAL DELIVERY WERE RECORDED ON (B)(4) 2014. THE PUMP ALARM HISTORY SHOWED NO ALARMS OUTSIDE THE RANGE OF NORMAL PATIENT USE. THE TOTAL DAILY DOSES ADDED UP CORRECTLY AND REFLECTED THE USERS PROGRAMMED BASAL RATE. THE PUMP SUCCESSFULLY PASSED A DELIVERY ACCURACY TEST AND WAS FOUND TO BE OPERATING WITHIN THE REQUIRED RANGE. PRODUCT ANALYSIS WAS UNABLE TO DUPLICATE THE REPORTED COMPLAINT. UNRELATED TO THE INITIAL COMPLAINT, THE BATTERY COMPARTMENT WAS OBSERVED TO BE CRACKED AT THE CASE SEAL. THE RETURNED BATTERY CAP WAS ABLE TO ATTACH TO THE PUMP AND WAS USED TO COMPLETE ALL TESTING.

    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 (INACCURATE DELIVERY) ISSUE. CUSTOMER SUPPORT DETERMINED THAT THE BASAL HISTORY TOTALS MATCHED THE TOTAL DAILY DELIVERY TOTALS. 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
    292124 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR