BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3035154 · Received April 4, 2013

    Report

    Report Number
    2531779-2013-03581
    Event Type
    Malfunction
    Date Received
    April 4, 2013
    Report Date
    March 11, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - DEVICE EVALUATION: THE RETURNED CARTRIDGE WAS EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE RETURNED CARTRIDGE PASSED VISUAL INSPECTION WITH NO DAMAGE OR DEFECTS NOTED IN THE LUER CONNECTION OR O-RINGS. A LEAK TEST WAS PERFORMED WITH NO FAILURES BEING OBSERVED. THERE WERE NO LEAKS OBSERVED FROM THE LUER CONNECTION, O-RINGS, OR ANYWHERE ELSE IN THE CARTRIDGE.

    Additional Manufacturer Narrative · 1

    FOLLOW UP #1 SUBMITTED: 05/28/2013 DEVICE EVALUATION: A RETAINED CARTRIDGE SAMPLE FROM LOT #B201927; A LEAK TEST WAS PERFORMED WITH NO FAILURES; NO LEAKS WERE OBSERVED FROM THE LUER CONNECTION, O-RINGS OR ELSEWHERE ON THE CARTRIDGE. REVIEW OF THE PUMP¿S BLACK BOX AND DOWNLOAD HISTORY REVEALED ¿PUMP NOT PRIMED¿ WARNINGS WITH ZERO FORCE RECORDED. A REWIND, LOAD AND PRIME SEQUENCE WAS SUCCESSFULLY PERFORMED WITHOUT ALARM. THE FORCE SENSOR WAS FOUND TO BE WITHIN SPECIFICATIONS. A LOSS OF PRIME WAS INDUCED DURING TESTING AND THE PUMP EMITTED THE APPROPRIATE AUDIBLE AND VIBRATORY ALERT. THE PUMP WAS OPENED FOR INVESTIGATION WITH NO EVIDENCE OF DAMAGE OR DEFECT NOTED TO THE INTERIOR COMPONENTS OF THE PUMP.

    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. 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) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A PRIME (LOAD STEP MALFUNCTION) ISSUE. 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
    138252 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR