BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4153021 · Received October 8, 2014

    Report

    Report Number
    2531779-2014-28662
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Report Date
    September 27, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    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.

    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-064 CALL SERVICE ALARM, WHICH CAN BE INDICATIVE OF THE TYPE OF ISSUE THAT WAS REPORTED, WAS OBSERVED IN THE BLACK BOX AND HISTORY DATA. THE PUMP WAS EXERCISED FOR 24 HOURS, DURING WHICH NO CS-064 CALL SERVICE ALARMS WERE OBSERVED: THE REPORTED ISSUE WAS NOT DUPLICATED. THE PUMP CASE WAS REMOVED, AND NO EVIDENCE OF INTERNAL DAMAGE OR DEFECT WAS FOUND. DURING ANALYSIS, THE PUMP OPERATED ACCORDING TO THE SPECIFICATIONS. A BATTERY CAP WAS NOT RETURNED WITH THE PUMP; A TEST BATTERY CAP WAS USED DURING THE ANALYSIS.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM (CS 064) ISSUE. IT WAS REPORTED THAT A CS-064 CALL SERVICE ALARM OCCURRED WHILE THE USER WAS PERFORMING A RANDOM FUNCTION. REPORTEDLY, THE USER HAD NOT RECEIVED MORE THAN ONE CS-064 CALL SERVICE ALARM OR OCCLUSION FOR THE SITE THEY WERE USING AT THAT TIME. 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
    631775 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR