BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 3041794 · Received April 8, 2013

    Report

    Report Number
    3008382007-2013-07227
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Report Date
    March 11, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K073231
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/PATIENT'S RELATIVE CONTACTED LIFESCAN USA ALLEGING THAT THE PATIENT WAS UNABLE TO OBTAIN A READING WITH THE SUBJECT METER. THE REPORTER INFORMED THE CUSTOMER CARE ADVOCATE THAT SHE WAS NOT PRESENT AT THE TIME THE ALLEGED ISSUE OCCURRED AND THEREFORE DID NOT KNOW WHAT THE SUBJECT METER WAS DOING OR NOT DOING. THE REPORTER CLAIMED THE ALLEGED METER ISSUE STARTED ON (B)(6) 2013 AT 12:21 PM. AT AN UNSPECIFIED TIME, PRIOR TO WHEN THE PATIENT ATTEMPTED TO TEST WITH THE SUBJECT METER, THE REPORTER CLAIMED THE PATIENT HAD DEVELOPED SYMPTOMS OF FEELING TIRED AND SHAKY. THE REPORTER DENIED THAT THE PATIENT RECEIVED MEDICAL TREATMENT DUE TO THE ALLEGED METER ISSUE. AT THE TIME OF THE CALL, THE REPORTER DID NOT HAVE THE SUBJECT METER WITH HER. ALTHOUGH THE PATIENT DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY, THERE IS NO INDICATION THAT THE REPORTED ISSUE CAUSED OR CONTRIBUTED TO THIS SERIOUS INJURY. THE PATIENT WAS SYMPTOMATIC PRIOR TO WHEN THE ALLEGED METER ISSUE BEGAN. HOWEVER, THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION BECAUSE THE ALLEGED ISSUE REMAINED UNRESOLVED AT THE TIME OF TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143717 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1