BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 2001318 · Received February 24, 2011

    Report

    Report Number
    2939301-2011-01632
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Report Date
    February 13, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DTHE 510 (K) # IS K073231. 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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (03/11/2011)-DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS/HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED TESTING WITH NO FAULTS FOUND. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    THE LAY USER/ PATIENT CONTACTED LFS ON LFS O N (B)(6) 2011 ALLEGING INACCURATE HIGH READINGS ON HER ONE TOUCH ULTRALINK METER. THE PATIENT MENTIONED THAT AT AN UNSPECIFIED TIME AT THE END OF (B)(6) 2011, THE PATIENT HAD DEVELOPED SYMPTOMS OF "HI BLOOD SUGAR". THE PATIENT THEN TESTED ON HIS ULTRALINK METER AND OBTAINED A 500 MG/DL . THE PATIENT DID NOT SELF-TREAT OR TAKE ANY ACTION AFTER OBTAINING THE ALLEGED HIGH READINGS. LESS THAN 30 MINUTES LATER, HE WENT TO THE ER AND OBTAINED A 240 MG/DL ON THE PHYSICIAN'S METER. HE WAS TREATED WITH HUMALOG INSULIN AND (B)(6) CRACKERS. THE TESTS STRIPS WERE IN GOOD CONDITION AND NOT EXPIRED. THE TEST STRIP VIAL WAS NOT CRACKED OR BROKEN. A QUALITY CONTROL TEST WAS NOT DONE SINCE THE PATIENT DID NOT HAVE ANY MORE SUBJECT TEST STRIPS. THE TECHNIQUE OF APPLYING BLOOD ON THE TEST STRIP WAS CORRECT. THE PRODUCT WAS REPLACED. AT THIS TIME THERE IS NO EVIDENCE THAT THE METER CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT, SINCE THE PATIENT DEVELOPED SYMPTOMS PRIOR TO TESTING AND TREATMENT IN ER CORRELATED TO LFS METER READING AND ER RESULT. THE COMPLAINT IS BEING REPORTED SINCE THE METER TO METER READINGS WERE GREATER THAN 30% OR 30 MG/DL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR