BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4171733 · Received October 14, 2014

    Report

    Report Number
    2531779-2014-29226
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Report Date
    October 2, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    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 12/09/2014 WITH THE FOLLOWING FINDINGS: THE PUMP POWERED ON WITH THE RETURNED BATTERY CAP. THE AUDIO BOLUS BUTTON COVER WAS DETACHED FROM THE PUMP. THERE WAS EVIDENCE OF MOISTURE CONTAMINATION ON THE UNDERSIDE OF THE BATTERY CAP. NO MOTOR REWIND ERRORS WERE OBSERVED IN THE PUMP'S BLACK BOX HOWEVER TWO CALL SERVICE 145 OCCLUSION ALARMS WERE PRESENT ON (B)(6) 2014. DURING INVESTIGATION, WHEN SELECTING REWIND, THE MOTOR LEAD-SCREW WOULD NOT MOVE. A VISUAL INSPECTION OF THE CARTRIDGE COMPARTMENT SHOWED THAT THE LEAD SCREW PISTON CAP HAD BECOME DETACHED AND LODGED IN THE LEAD-SCREW THREADS PREVENTING MOVEMENT. A LEAK TEST SHOWED A LEAK AT THE MISSING AUDIO BOLUS BUTTON COVER. THERE WAS NO EVIDENCE OF ADDITIONAL MOISTURE INSIDE THE PUMP. 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

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING THAT THE PISTON ROD WAS NOT RETRACTING DURING THE REWIND STEP. 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
    650102 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR