BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3811485 · Received May 15, 2014

    Report

    Report Number
    2531779-2014-13619
    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
    FL, US
    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

    (B)(4). DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/12/2014 WITH THE FOLLOWING FINDINGS: THE PUMP BOOTED TO THE VERIFY SCREEN WITH AUDIBLE AND VIBRATORY FEATURES. AN E-Z PRIME SEQUENCE AND 24 HOUR DURATION TEST WERE SUCCESSFULLY COMPLETED. THE PUMP HISTORY SHOWED NO ALARMS OUTSIDE OF THE RANGE OF NORMAL PATIENT USE. THE BASAL AND BOLUS TOTALS ADDED UP APPROPRIATELY TO THE TOTAL DAILY DOSE TOTAL INDICATING THAT THE PUMP WAS DELIVERING ACCURATELY UNTIL THE LAST DATE USED. THE PUMP SUCCESSFULLY PASSED A DELIVERY ACCURACY TEST AND WAS FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATION. PRODUCT ANALYSIS WAS UNABLE TO DUPLICATE THE REPORTED COMPLAINT. UNRELATED TO THE INITIAL COMPLAINT, THE DISPLAY SCREEN HAD A PINKISH CONTRAST BUT WAS STILL LEGIBLE.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A HISTORY/SETTINGS (HISTORY/SETTINGS ISSUE) ISSUE. THE REPORTER STATED THAT THE PATIENT MADE CHANGES TO THE BASAL PROGRAM AND THAT THE THE TOTAL DAILY DOSE BASAL DELIVERY TOTALS DID NOT MATCH THE BOLUS HISTORY 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
    292043 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR