BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4180781 · Received October 17, 2014

    Report

    Report Number
    2531779-2014-29580
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Report Date
    October 5, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 12/08/2014 WITH THE FOLLOWING FINDINGS: THE BASAL HISTORY REVEALED THAT ON (B)(6) 2014 AT 22:31 A 0.00 UNIT BASAL RATE WAS SET. ACCORDING TO THE BLACK BOX HISTORY, A REWIND, LOAD AND PRIME SEQUENCE WAS PERFORMED AT 22:44 FOLLOWED BY THE RE-ACTIVATION OF BASAL PROGRAM 1 AT 22:44. THERE WAS NO EVIDENCE OF ¿BASAL TURNED OFF BY USER¿ MESSAGE OBSERVED IN THE PUMP HISTORY ON (B)(6) 2014. THE PUMP WAS EXERCISED FOR 24 HOURS WITH A 1.00UNIT/HOUR BASAL PROGRAM; AT THE END OF THE DURATION, THE 1.0U BASAL PROGRAM REMAINED IN THE USERS SETTING WITH NO CHANGES OBSERVED. THERE WAS NO HYPERSENSITIVITY TO THE BUTTONS ON THE KEYPAD. THE ORIGINAL COMPLAINT COULD NOT BE DUPLICATED.

    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. IT WAS REPORTED THAT BASAL RATE WAS NOT STAYING CORRECTLY PROGRAMMED ON THE HOME SCREEN. 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
    662679 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR