BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 1821855 · Received August 31, 2010

    Report

    Report Number
    2939301-2010-07413
    Event Type
    Malfunction
    Date Received
    August 31, 2010
    Report Date
    August 10, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    MDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT'S PRODUCT(S) HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE FAILED TESTING. THE METER WAS FOUND TO HAVE A DEFECTIVE LCD. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A SECOND FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    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) 2010, THE PATIENT STARTED PERITONEAL DIALYSIS (PD) TREATMENT. ON (B)(6) 2010, THE PATIENT WAS DIAGNOSED WITH PERITONITIS. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. ON AN UNREPORTED DATE, THE PATIENT WAS HOSPITALIZED. ON (B)(6) 2010, A PERITONEAL EFFLUENT ANALYSIS AND CULTURE WERE PERFORMED. THE RESULTS OF THE CULTURE WERE UNKNOWN. ON AN UNKNOWN DATE IN 2010, THE PATIENT BEGAN REMEDIAL THERAPY WITH VANCOMYCIN (2GM, LOADING DOSE). PD THERAPY WAS ONGOING. IT WAS UNKNOWN WHETHER THE PERITONITIS RESOLVED. NO CONCOMITANT MEDICATIONS WERE REPORTED. NO STATEMENT OF CAUSALITY WAS REPORTED OF THE EVENT OF PERITONITIS.

    Description of Event or Problem · 1

    THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THE METER DOES NOT POWER ON. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WERE NO ALLEGATIONS OF HARM OR INJURY. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT MDS LIFESCAN, INC. 3029135

    Patients

    Seq Age Sex Outcome Treatment
    1