BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 3083850 · Received April 29, 2013

    Report

    Report Number
    3008382007-2013-09441
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Report Date
    April 2, 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
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE LFS PRODUCT(S) HAS BEEN REQUESTED FOR RETURN TO LIFESCAN FOR EVALUATION. IF THE SUBJECT PRODUCT IS RETURNED, AN EVALUATION WILL BE COMPLETED AND THE FINDINGS WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING SHE WAS OBTAINING INACCURATE RESULTS COMPARED TO THE SAME METER. THIS COMPLAINT WAS CLASSIFIED USING THE DOCUMENTATION FROM THE CUSTOMER CARE ADVOCATE (CCA) THE PATIENT REPORTED THE ALLEGED ISSUE FIRST OCCURRED ON (B)(6) 2013 AT 4AM. THE PATIENT ALLEGED OBTAINING READINGS OF "265, 178 AND 165MG/DL". THE PATIENT REPORTED ON AN UNKNOWN DATE AND TIME, SHE DEVELOPED SYMPTOMS OF "NECK PAIN." IT IS UNKNOWN IF THE PATIENT ATTRIBUTES THIS SYMPTOM WITH HIGH OR LOW BLOOD GLUCOSE. THE PATIENT DENIED RECEIVING ANY TREATMENT ON THE DAY OF THE ALLEGED ISSUE. THE ALLEGED ISSUE WAS NOT RESOLVED AT THE TIME OF TROUBLESHOOTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THERE IS NO INDICATION THAT THE SUBJECT METER CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT'S REPORTED SYMPTOMS DO NOT MEET LFS' CRITERIA FOR A SERIOUS INJURY. THE PATIENT DID NOT REPORT ANY BLOOD GLUCOSE READINGS, SYMPTOMS OR TREATMENT SUGGESTIVE THAT AN ACUTE COMPLICATION OF DIABETES OCCURRED. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE REMAINED UNRESOLVED WITH TROUBLESHOOTING DONE BY THE CCA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185854 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3400001

    Patients

    Seq Age Sex Outcome Treatment
    1