BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3083295 · Received April 29, 2013

    Report

    Report Number
    2531779-2013-05548
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Report Date
    April 4, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP #1 (B)(4) - DEVICE EVALUATION: ON EXAMINATION, THE DISPLAY IS DAMAGED AND CRACKED IN MULTIPLE PLACES. THE DISPLAY REMAINS BLANK WHEN THE PUMP IS POWERED ON. A TEST DISPLAY WAS ATTACHED TO THE PUMP AND ILLUMINATED PROPERLY.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING THAT THE DISPLAY SCREEN WAS HAD A THIN RED AND GREEN LINE ON IT AND THEN IT BECAME BLANK. THE PATIENT STATED THAT THE ISSUE BEGAN WHEN HE FELL ON THE PUMP. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE DEVICE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183991 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR