BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 2123688 · Received June 14, 2011

    Report

    Report Number
    2939301-2011-04800
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    May 29, 2011
    Report Date
    June 1, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 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.

    Description of Event or Problem · 1

    THE LAY USER / PATIENT CONTACTED LFS ON (B)(6) 2011 ALLEGING INACCURATE ERRATIC READINGS ON THEIR ONE TOUCH ULTRALINK METER. THE PATIENT MENTIONED THAT THE ALLEGED ISSUE BEGAN ON (B)(6) 2011 AT AROUND 1:39PM. THE PATIENT HAD TESTED AND OBTAINED A 151 MG/DL, 141, 136 AND 105 MG/DL. READINGS WERE TAKEN LESS THAN 20 MINUTES FROM ONE ANOTHER. AN HOUR AFTER TESTING THE PATIENT DEVELOPED SYMPTOMS OF FEELING SHAKY. THE PATIENT TESTED ON AN ACCUCHECK METER; HOWEVER, DOES NOT RECALL THE READING. THE PATIENT SELF-TREATED WITH FOOD/DRINK AND DID NOT SEEK ANY FURTHER MEDICAL ATTENTION OR CONTACT THEIR PHYSICIAN FOR ASSISTANCE. A QUALITY CONTROL TEST WAS NOT DONE SINCE THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT MENTIONED THAT DUE TO THE ALLEGED HIGH READINGS, HE LATER DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AND HAD TO SELF-TREAT WITH FOOD/DRINK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3052606

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Life Threatening| R