BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VITA METER

    MDR report key: 1920284 · Received December 10, 2010

    Report

    Report Number
    2939301-2010-10671
    Event Type
    Injury
    Date Received
    December 10, 2010
    Date of Event
    December 10, 2010
    Report Date
    December 10, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510 (K) # IS K082513. 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 REPORTER/ HUSBAND CONTACTED LFS ON (B)(6) 2010 ALLEGING INACCURATE HIGH READINGS ON HIS WIFE'S ONE TOUCH VITA METER. THE REPORTER MENTIONED THAT HIS WIFE COMPARED HER TO ANOTHER METER IN THE PHARMACY TODAY AND THEY NOTICED A DIFFERENCE IN THE READINGS. AT NOON ON (B)(6) 2010, THE PATIENT OBTAINED A 130 MG/DL ON THE LFS AND ON THE OTHER METER IN THE PHARMACY , THE PATIENT'S BLOOD GLUCOSE WAS 144 MG/DL AT 12:08PM. APPROXIMATELY 10 MINUTES LATER, THE PATIENT DEVELOPED SYMPTOMS OF FEELING HOT, SWEATY AND FELL DOWN. THE PATIENT THEN SELF-TREATED WITH SUGAR, INSTEAD OF TAKING HER "NORMAL" DOSAGE OF INSULIN. THE PATIENT DID NOT SEEK ANY FURTHER MEDICAL ATTENTION OR CONTACT HER PHYSICIAN FOR ASSISTANCE. THE PATIENT DID A BACK TO BACK TEST OVER THE PHONE WITH THE CUSTOMER CARE ADVOCATE (CCA) AND OBTAINED A 220 MG/DL AND A 223 MG/DL. THE HUSBAND WAS UNCOMFORTABLE WITH THE METER AND WANTED A REPLACEMENT METER. HE FELT THAT HIS WIFE COULD POTENTIALLY TAKE MORE INSULIN THAN NEEDED IF THE METER IS INACCURATE. THE TEST STRIPS WERE IN GOOD CONDITION AND NOT EXPIRED AND THE TEST STRIP VIAL WAS NOT CRACKED OR BROKEN. A QUALITY CONTROL TEST WAS NOT DONE SINCE THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION. THE METER WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGEDLY OBTAINED A HIGH READING AND SHORTLY LATER DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AND HAD TO SELF-TREAT WITH FOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT VITA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3024696

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Life Threatening| R