BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4121919 · Received September 26, 2014

    Report

    Report Number
    2531779-2014-27652
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Report Date
    September 13, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED, AND IT WAS EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE OCCURRENCE OF A CS-078 CALL SERVICE ALARM WAS VERIFIED USING THE BLACK BOX AND HISTORY DATA. RELATED TO THE REPORTED ISSUE, A CS-064 CALL SERVICE ALARM, WHICH, LIKE A CS-078 CALL SERVICE ALARM, PERTAINS TO MOTOR FUNCTION, WAS OBSERVED DURING THE INVESTIGATION. THE PUMP CASE WAS REMOVED, AND CORROSION WAS FOUND ON THE MOTOR FLEX CONNECTOR; THIS DEVICE FAILURE DIRECTLY CAUSED THE REPORTED ISSUE. THE BATTERY COMPARTMENT WAS CRACKED FROM THE GRIP PAD TO THE CASE SEAL; THE RELATION OF THIS DEVICE FAILURE TO THE REPORTED ISSUE COULD NOT BE DETERMINED, AS A LEAK TEST WAS NOT PERFORMED. A BATTERY CAP WAS NOT RETURNED WITH THE PUMP; A TEST BATTERY CAP WAS USED DURING THE ANALYSIS.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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 CALL SERVICE ALARM (CS 078) ISSUE. IT WAS REPORTED THAT A CS-078 CALL SERVICE ALARM OCCURRED 3 OR MORE TIMES WITHIN A 30 DAY PERIOD. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED 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
    600652 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR