BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3192365 · Received June 27, 2013

    Report

    Report Number
    2531779-2013-09071
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    June 1, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. 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 DATE OF SUBMISSION 08/13/2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/17/2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX INDICATED TWO ¿NO CARTRIDGE DETECTED¿ WARNINGS AND MULTIPLE ¿LOSS OF PRIME¿ WARNINGS ON THE REPORTED EVENT DATE. THE PUMP POWERED ON APPROPRIATELY TO THE VERIFY SCREEN. THE REWIND STEP WAS SUCCESSFULLY PERFORMED, BUT THE PUMP WAS UNABLE TO DETECT THE CARTRIDGE DURING THE LOAD STEP. INVESTIGATION REVEALED BROKEN SOLDER JOINTS TO BOTH FORCE SENSOR FLEX PINS, LEADING TO AN INTERMITTENT CONDITION.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A PRIME (LOAD STEP MALFUNCTION) ISSUE. THE REPORTER STATED THAT WHILE LOADING THE CARTRIDGE THE PUMP DISPENSED ALL THE INSULIN AND THEN EMITTED A NO CARTRIDGE DETECTED WARNING. 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
    293998 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR