BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3181334 · Received June 21, 2013

    Report

    Report Number
    2531779-2013-08703
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Report Date
    May 22, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 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

    FOLLOW-UP # 1 DATE OF SUBMISSION 08/13/2013 -DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4)2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP¿S HISTORY SHOWED NO EVIDENCE OF A LOAD STEP MALFUNCTION. DURING TESTING, THE PUMP POWERED ON NORMALLY AND DISPLAYED THE VERIFY SCREEN. THE PUMP WAS ABLE TO PRIME CORRECTLY AND THERE WAS NO LOAD STEP MALFUNCTION DURING TESTING. THE FORCE SENSOR CALIBRATION WAS FOUND TO BE WITHIN SPECIFICATIONS. THE PUMP¿S COVER WAS REMOVED AND THE FORCE SENSOR FLEX WAS FOUND TO BE INTERMITTENTLY CONNECTED DUE TO A CRACKED TRACE NEAR THE FORCE SENSOR PIN.

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT THE PUMP DISPENSED INSULIN INTO THE TUBING DURING THE LOAD CARTRIDGE STEP. THERE WAS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS INCIDENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE COULD NOT BE RESOLVED DURING TROUBLE SHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283424 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR