BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3002274 · Received March 13, 2013

    Report

    Report Number
    2531779-2013-02671
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Report Date
    February 27, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION FOLLOW-UP #1 SUBMITTED (B)(4) 2013: THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING RESULTS: NO DEFECT WAS FOUND. LOSS OF PRIMES WITH ZERO FORCE OBSERVED IN THE BLACK BOX. THE CARTRIDGE CAP WAS NOT RETURNED WITH THE PUMP FOR INVESTIGATION; A TEST CARTRIDGE CAP WAS USED FOR ALL INVESTIGATION STEPS. REWIND, LOAD CARTRIDGE, AND PRIME STEPS PERFORMED SUCCESSFULLY WITH NO ALARMS. A FORCE SENSOR CALIBRATION TEST CONFIRMED THE SENSOR IS DETECTING CORRECT FORCE AT 5LBS. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO LOSS OF PRIMES OCCURRING. WHEN THE CARTRIDGE CAP WAS REMOVED PUMP GAVE APPROPRIATE ¿PUMP NOT PRIMED¿ WARNING. THE PUMP WAS OPENED AND NO DAMAGE WAS FOUND TO THE FORCE SENSOR CIRCUIT. UNABLE TO VERIFY OR DUPLICATE REPORTED PUMP MAINTAINING PRIME WITHOUT A CARTRIDGE CAP.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. 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

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THAT THE PUMP DOES NOT GIVE A LOSS OF PRIME WARNING. UPON TROUBLESHOOTING THE PUMP THE PATIENT WAS ABLE TO REMOVE HER CARTRIDGE CAP AND NO LOSS OF PRIME WARNING WAS EMITTED. THE PATIENT THEN REMOVED THE CARTRIDGE AND THEN AFTER A FEW MINUTES THE PUMP EMITTED A LOSS OF PRIME WARNING. THE PATIENT REFUSED TO TROUBLESHOOT. THERE IS NO REPORTED ADVERSE EVENT WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON THE ALLEGATION OF THE PRIME ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104633 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR