BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3021340 · Received March 26, 2013

    Report

    Report Number
    2531779-2013-03066
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Report Date
    February 28, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. 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. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW UP #1 SUBMITTED: (B)(4) 2013. DEVICE EVALUATION: REVIEW OF THE BLACK BOX AND DOWNLOAD HISTORY REVEALED NO ACTIVITY OUTSIDE NORMAL USE. THERE WERE NO ¿LOAD STEP MALFUNCTION¿ OR ¿LOSS OF PRIME¿ WARNINGS RECORDED. ON TESTING, THE PUMP POWERED ON NORMALLY AND SUCCESSFULLY PERFORMED THE LOAD STEP WITHOUT ALARM. THE FORCE SENSOR WAS NOTED TO BE WITHIN SPECIFICATIONS. THE PUMP WAS OPENED FOR INVESTIGATION AND DID NOT REVEAL ANY EVIDENCE OF DEFECT OR DAMAGE OF THE INTERIOR COMPONENTS.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A PRIME (LOAD STEP MALFUNCTION) ISSUE. THE PUMP REPORTEDLY DISPENSED INSULIN DURING THE LOAD CARTRIDGE 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
    122917 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR