BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4171699 · Received October 14, 2014

    Report

    Report Number
    2531779-2014-29193
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Report Date
    September 30, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/12/2014 WITH THE FOLLOWING FINDINGS: THERE WERE NO OCCLUSION ALARMS RECORDED IN THE BLACK BOX DUE TO BEING OVERWRITTEN WITH CONTINUED USE. THE HISTORY DID RECORD OCCLUSION ALARMS. UNABLE TO DUPLICATE ANY OCCLUSIONS DURING INVESTIGATION. FORCE SENSOR CALIBRATION READING WAS IN SPECIFICATIONS.

    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

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2014 ALLEGING AN OCCLUSION (FREQUENT/PERSISTENT) ISSUE. THE REPORTER STATED THAT THE PATIENT HAD A BLOOD GLUCOSE (BG) OF 250 MG/DL WITH POLYDYPSIA AND IRRITABILITY. THE REPORTED BG WAS NOT INDICATIVE OF A SERIOUS INJURY AND DOES NOT MEET THE ANIMAS CRITERIA OF AN ADVERSE EVENT. THE PATIENT DID NOT RECEIVE ANY TREATMENT ABOVE AND BEYOND THE USUAL ROUTINE CARE OF DIABETES MANAGEMENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650149 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR