BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VITA METER

    MDR report key: 2860927 · Received December 6, 2012

    Report

    Report Number
    3008382007-2012-07356
    Event Type
    Injury
    Date Received
    December 6, 2012
    Date of Event
    November 27, 2012
    Report Date
    November 28, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K082513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCTS WERE REPLACED AND REQUESTED BACK FOR INVESTIGATION. 510 (K) K082513.

    Description of Event or Problem · 1

    THE LAY USER /PATIENT CONTACTED LFS (B)(4) ON (B)(6) 2012 ALLEGING INACCURATE HIGH READINGS ON HER ONE TOUCH VITA METER COMPARED TO HER BACK UP VITA METER. 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 WAS CLASSIFIED BASED ON THE INITIAL CALL THE PATIENT MADE ON (B)(6) 2012: THE PATIENT MENTIONED THAT SHE HAS HAD A STRESSFUL DAY ON (B)(6) 2012. SHE HAD TESTED HER BLOOD GLUCOSE ON HER VITA METER AND OBTAINED A 116 MG/D AND A COUPLE OF MINUTES LATER THE PATIENT DEVELOPED SYMPTOMS OF FEELING SHAKY, ANXIOUS AND THEN TESTED HER BLOOD PRESSURE AND IT WAS HIGH. SHE THEN TESTED ON HER BACK UP VITA METER LESS THAN 30 MINUTES LATER AND OBTAINED AN 85 MG/DL. SHE THEN ATE 2-3 PIECES OF "CHRISTSTOLLEN" AND A HUGE PORTION OF ICE CREAM AND FELT BETTER AFTER EATING AND THEN WENT TO BED. SHE TESTED ON THE MORNING OF (B)(6) 2012 AND HER READING WAS NORMAL. THE TECHNIQUE OF APPLYING BLOOD ON THE TEST STRIP WAS CORRECT. THE TEST 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 CONTROL SOLUTION. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE ALLEGED HIGH READINGS, THE PATIENT DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AND HAD TO SELF-TREAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT VITA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3265694

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Life Threatening| R