BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4130986 · Received September 30, 2014

    Report

    Report Number
    2531779-2014-27971
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Report Date
    September 28, 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

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 12/12/2014 WITH THE FOLLOWING FINDINGS: THE BLACK BOX AND HISTORY RECORDS OF THE PUMP WERE REVIEWED. PUMP HISTORY SHOWS THE LAST BASAL DELIVERY AND THE LAST BOLUS WERE ON (B)(6) 2014. THE TOTAL DAILY DOSES CORRECTLY REFLECT THE USERS PROGRAMMED BASAL AND BOLUS DELIVERIES. NO ALARMS RELATED TO THE COMPLAINT OBSERVED IN ALARM HISTORY. THE PUMP PASSED A DELIVERY ACCURACY TEST AND WAS FOUND TO BE OPERATING WITHIN REQUIRED RANGE AND DELIVERING ACCURATELY. INVESTIGATORS WERE UNABLE TO DUPLICATE THE COMPLAINT. THE DISPLAY SCREEN WAS OBSERVED TO HAVE A PINKISH CONTRAST. 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

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2014 ALLEGING A HISTORY SETTINGS (INACCURATE DELIVERY) ISSUE. THE REPORTER STATED THAT THE PATIENT HAD A BLOOD GLUCOSE (BG) OF 27MMOL/L WITH NAUSEA. THE REPORTED BG WAS NOT INDICATIVE OF A SERIOUS INJURY AND DOES NOT MEET THE ANIMAS CRITERIA OF AN ADVERSE EVENT. CUSTOMER SUPPORT (CS) REVIEWED THE PUMP AND ALL SETTINGS WERE CORRECT. THE PATIENT REFUSED TO RETURN THE PUMP. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE DEVICE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609391 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR