BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 1880733 · Received October 25, 2010

    Report

    Report Number
    2939301-2010-09332
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Report Date
    October 19, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP # 1/SUPPLEMENTAL REPORT TEXT-(B)(4) 2010.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 PCB CONTAMINATION. 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; 510 (K) # IS K073231 (UL).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT IN (B)(6) 2008, THE PATIENT EXPERIENCED UNSTABLE ANGINA PECTORIS. IN (B)(6) 2009, A 6-MONTH FOLLOW-UP WAS PERFORMED. IN (B)(6) 2009, A 1 YEAR FOLLOW-UP WAS PERFORMED. THE PATIENT HAD NO ANGINAL SYMPTOMS. IT WAS INDICATED THAT ASPIRIN WAS PRESCRIBED FROM (B)(6) 2008 TO (B)(6) 2010 AND CANCELLED DUE TO BLEEDING FROM THE WOUNDED AREA. CLOPIDOGREL WAS ALSO PRESCRIBED FROM (B)(6) 2008 TO (B)(6) 2010 AND CANCELLED DUE TO BLEEDING FROM THE WOUNDED AREA. THE PHYSICIAN LATER PRESCRIBED ASPIRIN AND CLOPIDOGREL AND WAS STARTED AGAIN IN (B)(6) 2010. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. IN SEPTEMBER 2010, A 2 YEAR FOLLOW-UP WAS PERFORMED. NO ANGINAL SYMPTOMS WERE NOTED.

    Description of Event or Problem · 1

    THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THE METER DOES NOT POWER ON WITH STRIP INSERTION. 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 NBW LIFESCAN, INC. 3037509

    Patients

    Seq Age Sex Outcome Treatment
    1