BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3023545 · Received March 27, 2013

    Report

    Report Number
    2531779-2013-03145
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Report Date
    February 25, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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.

    Additional Manufacturer Narrative · 1

    FOLLOW UP #1 SUBMITTED: 06/12/2013 DEVICE 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. REVIEW OF THE BLACK BOX AND DOWNLOAD HISTORY REVEALED DATA FROM THE DATE OF THE ALLEGED EVENT HAD BEEN OVERWRITTEN DUE TO CONTINUED PATIENT USE. THERE WAS NO EVIDENCE OF ACTIVITY OUTSIDE NORMAL USE RECORDED. THERE WERE NO ¿LOAD STEP MALFUNCTION¿ OR ¿LOSS OF PRIME¿ RECORDED IN THE HISTORY. ON INVESTIGATION, THE PUMP POWERED ON NORMALLY. THE LOAD STEP WAS PERFORMED WITHOUT A LOAD STEP MALFUNCTION AND THE PUMP PRIMED CORRECTLY. THE FORCE SENSOR WAS FOUND TO BE WITHIN SPECIFICATIONS. THE PUMP WAS OPENED FOR INVESTIGATION AND DID NOT REVEAL EVIDENCE OF CONTAMINATION, DEFECT OR DAMAGE OF THE INTERIOR PUMP COMPONENTS. THE COMPLAINT WAS NOT ABLE TO BE CONFIRMED OR DUPLICATED DURING INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A PRIME (LOAD STEP MALFUNCTION) ISSUE. IT WAS REPORTED THAT THE PUMP WAS PRIMING 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
    126589 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR