BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2972329 · Received February 21, 2013

    Report

    Report Number
    2531779-2013-02002
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Report Date
    January 31, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION FOLLOW-UP #1 (B)(4)013: NO CARTRIDGE WAS RETURNED FOR INVESTIGATION; A RETAIN SAMPLE FORM THE SAME LOT (B201867) WAS PULLED FOR INVESTIGATION AND PASSED VISUAL, FILL, AND FORCE TESTS. EACH CARTRIDGE LOT IS SUBJECTED TO A STATISTICAL SAMPLING PLAN AND MUST PASS TESTING FOR FORCE (OCCLUSION AND LOSS OF PRIME), CRACKS, AND FOREIGN MATERIAL PRIOR TO RELEASE FOR DISTRIBUTION.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 (B)(4) -DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: BLACK BOX SHOWS 'LOSS OF PRIME' WARNING DUE A LOW NON-ZERO FORCE ON THE REPORTED FAILURE DATE. THE PUMP POWERS UP NORMALLY AND PASSES 'EZ-PRIME' STEPS SUCCESSFULLY, THE PUMP WAS FOUND TO BE ABLE TO PRIME AND DELIVER CORRECTLY. FORCE SENSOR CALIBRATION IS ABOVE THE REQUIRED SPECIFICATIONS. DURING TESTING, A 'LOSS OF PRIME' WAS STIMULATED BY LOOSING UP THE CARTRIDGE CAP; THE PUMP GAVE THE APPROPRIATE AUDIBLE AND VISIBLE ALERT UPON THE FIRST FORCE DROP. THE PUMP WAS OPENED, NO MOISTURE INGRESS IS OBSERVED INSIDE THE PUMP. THE FORCE SENSOR AND THE POWER CIRCUIT WERE TESTED FOR INTERMITTENT CONDITION OR DAMAGE, NONE WAS FOUND. THE FORCE SENSOR RESISTANCE READING IS WITHIN SPECIFICATIONS.

    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 (PRIME ISSUE) 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
    75674 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR