BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VITA METER

    MDR report key: 1986544 · Received February 11, 2011

    Report

    Report Number
    2939301-2011-01303
    Event Type
    Injury
    Date Received
    February 11, 2011
    Date of Event
    January 29, 2011
    Report Date
    February 9, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 USER / PATIENT CONTACTED LFS (B)(4) ON (B)(6) 2011 ALLEGING INACCURATE HIGH READINGS ON HIS ONE TOUCH VITA METER COMPARED TO THE LAB. A MEDICAL SURVEILLANCE SPECIALIST (MSS) SENT FOLLOW UP QUESTIONS; HOWEVER, THE CUSTOMER CARE ADVOCATE (CCA) WAS UNSUCCESSFUL IN GETTING A HOLD OF THE PATIENT. THE FOLLOWING IS BASED ON THE INITIAL CALL PLACED ON (B)(6) 2011. ON (B)(6) 2011, THE PATIENT TESTED IN THE LAB AND OBTAINED A 177 MG/DL AND HIS METER READ 299 MG/DL. AFTER TESTING ON HIS METER, THE PATIENT TOOK "1 MORE UNIT OF NEW RAPID" INSULIN, BASED ON HIS SLIDING SCALE. HE DEVELOPED SYMPTOMS OF "HYPOGLYCEMIA" 20 MINUTES LATER. HE DID NOT ATTEMPT TO RETEST AND WAS NOT TESTED ON ANOTHER DEVICE. HE TREATED HIMSELF WITH 3 SUGAR CUBES. HE DID NOT SEEK ANY FURTHER MEDICAL ATTENTION OR CONTACT HIS PHYSICIAN FOR ASSISTANCE. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT HE TOOK AN EXTRA UNIT OF INSULIN BASED ON HIS METER READING AND LATER DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AND HAD TO SELF-TREAT WITH SUGAR.

    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 46 YR Life Threatening| R