BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3143205 · Received June 3, 2013

    Report

    Report Number
    2531779-2013-07518
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Report Date
    May 10, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS BUT 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

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/08/2013 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, A REWIND, LOAD AND PRIME SEQUENCE WERE PERFORMED SUCCESSFULLY WITH NO ISSUES. THE BLACK BOX HISTORY WAS REVIEWED AND SHOWED NO DELIVERY, NO PRIME, AND NO CARTRIDGE DETECTED WARNINGS ON 05/10/2013 AND 05/12/2013. THE FORCE SENSOR CALIBRATION AND FORCE SENSOR RESISTANCE WERE FOUND NOT TO BE WITHIN SPECIFICATIONS. THE PUMP COVER WAS REMOVED AND INTERNAL MOISTURE WAS OBSERVED IN THE PUMP AND ON THE FORCE SENSOR PINS. THE LOAD STEP ISSUE WAS RECORDED IN THE PUMP HISTORY BUT WAS NOT DUPLICATED DURING THE INVESTIGATION. 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. THE CARTRIDGE WAS RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/25/2013 WITH THE FOLLOWING FINDINGS: A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED AND NO DAMAGE OR DEFECTS WERE FOUND.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT CONTACTED ANIMAS, ALLEGING A PRIME (LOAD STEP MALFUNCTION) ISSUE. THE PATIENT REPORTEDLY RECEIVED A "NO CARTRIDGE DETECTED" WARNING AND THE PUMP REPORTEDLY DISPENSED INSULIN DURING THE LOAD 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
    244002 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR