BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VITA METER

    MDR report key: 2351125 · Received November 29, 2011

    Report

    Report Number
    2939301-2011-11579
    Event Type
    Injury
    Date Received
    November 29, 2011
    Date of Event
    November 12, 2011
    Report Date
    November 14, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    PATIENT

    Narratives

    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. THE 510K # IS K082513.

    Description of Event or Problem · 1

    THE LAY REPORTER CONTACTED LFS (B)(4) ON (B)(6) 2011 ALLEGING ERRATIC READINGS ON HIS FATHER'S ONE TOUCH VITA METER FOR APPROXIMATELY A MONTH NOW . ON (B)(6) 2011, THE PATIENT HAD DONE BACK TO BACK TESTING PRIOR TO THE SYMPTOMS AND THE READINGS WERE DIFFERENT FROM ONE ANOTHER. HE MENTIONED THAT HE HAD OBTAINED A 280 MG/DL AND THEN RETEST AND OBTAIN A 95 MG/DL. DUE TO THE INACCURATE READING, HE CHANGED HIS INSULIN DOSAGE AND LATER DEVELOPED SYMPTOMS. THE PATIENT HAD DEVELOPED SYMPTOMS OF FEELING DIZZY, SWEATY AND ALMOST FAINTED. THERE IS NO INFORMATION ON WHETHER THE PATIENT SOUGHT ANY MEDICAL ATTENTION DUE TO THE ALLEGED SYMPTOMS. THE REPORTER MENTIONED THAT THIS WAS ONE EXAMPLE AND THERE HAS BEEN SEVERAL OTHER HYPOGLYCAEMIC SYMPTOMS DUE HIS FATHER ADJUSTING HIS INSULIN BASED ON THE METER READINGS. REPORTER MENTIONED THAT HE MADE COMPARISON TEST WITH A FAMILY'S ONE TOUCH ULTRA EASY METER AND PER THE PATIENT, THE RELATIVES METER WAS MORE ACCURATE THAN THE PATIENT'S METER. THE REPORTER DID NOT HAVE THE SUPPLIES TO TROUBLESHOOT THE PRODUCT. THE PRODUCTS WERE REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE REPORTER ALLEGED THAT DUE TO THE ALLEGED ERRATIC READINGS ON HIS FATHER'S METER, HE ADJUSTED HIS INSULIN AND LATER DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening