BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2833995 · Received November 15, 2012

    Report

    Report Number
    2531779-2012-13655
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Report Date
    October 19, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUBMITTED (B)(4) 2013 FOLLOW-UP # 1 - THE PUMP WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012: NO DEFECT WAS FOUND. THE BLACK BOX REVIEW SHOWS A MANUAL TIME/DATE CORRECTION ON THE REPORTED DATE FROM (B)(6) 2012. NO ACTIVITY OUTSIDE NORMAL USE OBSERVED IN THE BLACK BOX OR HISTORY DOWNLOAD DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER'S PROGRAMMED BASAL RATES. THE PUMP BOOTS UP NORMALLY, PERFORMED MULTIPLE "EZ-PRIME" OPERATIONS SUCCESSFULLY AND EXERCISED THE PUMP FOR 6 DAYS. NO ALARMS DUPLICATED DURING TESTING .THE UNIT PASSES "TIME TEST" SUCCESSFULLY AND FOUND ABLE TO KEEP "TIME/DATE" SETTINGS ACCURATELY DURING TESTING. OPENED THE PUMP TO INVESTIGATE, NO DAMAGE OR MOISTURE INGRESS WERE FOUND TO THE POWER CIRCUITS OR THE PCB.

    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) 2012, THE REPORTER CONTACTED ANIMAS FOR AN UNRELATED ISSUE AND DURING TROUBLESHOOTING FOUND THAT THE PUMP'S TIME WAS CORRECT BUT THE DATE WAS INCORRECT IN THE PUMP HISTORIES. THE REPORTER NOTED THAT THE PUMP'S DATE FOR THAT DAY'S RECORDS WAS (B)(6) 2012, WHEN THE DATE WAS REALLY (B)(6) 2012. THE REPORTER COULD NOT EXPLAIN HOW THE DATE COULD HAVE BECOME OFF BY A DAY. 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
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR