BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3900339 · Received June 27, 2014

    Report

    Report Number
    2531779-2014-18564
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Report Date
    June 25, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1; DATE OF SUBMISSION: 08/27/2014 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED, AND IT WAS EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: A CS-052 CALL SERVICE ALARM, FOLLOWED BY A REBOOT EVENT TO CLEAR THE ALARM, WAS OBSERVED IN THE BLACK BOX DATA. SUBSEQUENTLY, THE TIME AND DATE WERE RESET, AND A CS-054 CALL SERVICE ALARM OCCURRED. THESE FINDINGS ARE INDICATIVE OF THE EVENT REPORTED IN THE INITIAL COMPLAINT. DURING ANALYSIS, THE PUMP POWERED ON WITH THE RETURNED BATTERY CAP, WHICH WAS UNABLE TO FULLY TIGHTEN DUE TO AN UNRELATED CASING AND CAP DAMAGE ISSUE. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO REBOOT, LOSS OF POWER, OR CALL SERVICE ALARMS OBSERVED. A POWER-LOSS EVENT WAS NOT OBSERVED DURING ANALYSIS; THE REPORTED EVENT WAS NOT DUPLICATED. UNRELATED TO THE REPORTED EVENT, THE BATTERY COMPARTMENT WAS CRACKED BELOW THE GRIP PAD, AND THE CARTRIDGE COMPARTMENT WAS CRACKED IN THE THREAD AREA. THE THREADS OF THE BATTERY COMPARTMENT AND CAP WERE DAMAGED, AND EVIDENCE OF MOISTURE INGRESS WAS FOUND ON THE UNDERSIDE OF THE BATTERY CAP. THE PUMP FAILED A LEAK TEST AT THE CRACK IN THE CARTRIDGE COMPARTMENT. THE PUMP CASE WAS REMOVED, AND EVIDENCE OF ADDITIONAL MOISTURE INGRESS WAS OBSERVED ON INTERNAL COMPONENTS. ALSO UNRELATED TO THE REPORTED EVENT, THE DISPLAY SCREEN WAS FOUND TO BE DIM AND DISCOLORED.

    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 POWER (NO POWER) ISSUE. 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
    376572 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR