BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3895681 · Received June 25, 2014

    Report

    Report Number
    2531779-2014-18293
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Report Date
    June 23, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    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

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/14/2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP¿S BLACK BOX HISTORY SHOWED THAT A ¿NO CARTRIDGE DETECTED¿ ALARM WAS RECORDED. DURING TESTING, THE PUMP POWERED UP AND IMMEDIATELY EMITTED A REPLACE BATTERY ALARM. THE PUMP CASE WAS REMOVED AND CORROSION WAS FOUND ON MULTIPLE COMPONENTS OF THE PRINTED CIRCUIT BOARD AS WELL AS ON THE FORCE SENSOR FLEX CONNECTOR. THE COMPLAINT THAT THE PUMP WAS PRIMING THE TUBING WHEN PERFORMING THE LOAD STEP WAS NOT ABLE TO BE ADEQUATELY INVESTIGATED DUE TO THE REPLACE BATTERY ALARM AND CORROSION 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 A PRIME (LOAD STEP MALFUNCTION) ISSUE. THE REPORTER ALLEGED THAT THE PUMP PRIMED THE TUBING DURING THE LOAD STEP. IT WAS NOTED THAT THE PUMP EMITTED A "NO CARTRIDGE DETECTED" ALARM. 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
    372061 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR