BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO METER

    MDR report key: 2500727 · Received March 22, 2012

    Report

    Report Number
    3008382007-2012-01073
    Event Type
    Injury
    Date Received
    March 22, 2012
    Report Date
    March 17, 2011
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510 (K) IS K093745 FOR THE ONETOUCH VERIO TEST STRIPS. DEVICE EVALUATION: LIFESCAN RECEIVED THE METER AND TEST STRIPS INVOLVED WITH THIS COMPLAINT AND COMPLETED DEVICE EVALUATION ON 04/07/2011 AND 03/17/2011, RESPECTIVELY. INVESTIGATION WAS UNABLE TO CONFIRM THE ALLEGED COMPLAINT WITH THE RETURNED METER; HOWEVER, FOUND THAT THE LCD WAS SCRATCHED. THE ALLEGED "ERROR 4" COMPLAINT WAS CONFIRMED WITH THE RETURNED TEST STRIPS. TESTING WITH RETAIN TEST STRIPS WAS PERFORMED AND THE TESTING PASSED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING AN "ERROR 4" MESSAGE ON HIS ONE TOUCH VERIOPRO METER. THE PATIENT MENTIONED THAT HE HAD OBTAINED AN ERROR 4 MESSAGE ON HIS ONE TOUCH VERIOPRO METER AT 11:30PM ON (B)(6) 2011. APPROXIMATELY 1-2 HOURS LATER, THE PATIENT DEVELOPED SYMPTOMS OF FEELING SHAKY, COLD SWEATS, HEADACHE AND FREQUENT URINATION. THE PATIENT CONTACTED HIS PHYSICIAN FOR ADVICE AND WAS ADVISED TO TAKE "PARACETAMOL" 500 MG. THE PATIENT TOOK THE ADVICE OF THE PHYSICIAN AND DID NOT SEEK ANY FURTHER MEDICAL ATTENTION OR TEST ON ANOTHER DEVICE. THE TEST STRIPS WERE IN GOOD CONDITION AND NOT EXPIRED. THIS IS NOT THE FIRST TIME THE PRODUCT WAS BEING USED. WHILE TROUBLESHOOTING THE ALLEGED ISSUE WAS NOT RESOLVED. PRODUCTS WERE REPLACED. THERE WAS INDICATION THAT THE PRODUCT MAY HAVE CONTRIBUTED TO AN ADVERSE EVENT SINCE THE PATIENT DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY, AFTER BEING UNABLE TO TEST DUE TO AN ALLEGED "ERROR 4" MESSAGE ON HIS ONETOUCH VERIO METER. IN ADDITION, THE REPORTED "ERROR 4" ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THE COMPLAINT WAS INITIALLY RULED OUT AS A REPORTABLE MDR BECAUSE LFS DID NOT HAVE 510K CLEARANCE ON THE ONETOUCH VERIO PRODUCTS AT THE TIME OF THE COMPLAINT. THIS COMPLAINT IS NOW BEING REPORTED DUE TO DEVICE EVALUATION INVESTIGATION RESULTS THAT WERE COMPLETED ON 03/17/2011, WHICH IS AFTER LFS RECEIVED 510K CLEARANCE ON THE ONETOUCH VERIO PRODUCT (510 (K) IS K093745).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT VERIO METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3078404

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Life Threatening