BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO METER

    MDR report key: 2252121 · Received September 16, 2011

    Report

    Report Number
    3008382007-2011-00420
    Event Type
    Injury
    Date Received
    September 16, 2011
    Date of Event
    September 14, 2011
    Report Date
    September 15, 2011
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    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 K093745.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ((B)(6) 2011)-DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED TESTING WITH NO FAULTS FOUND. A DHR (DEVICE HISTORY RECORD) WAS COMPLETED FOR THIS PRODUCT AND NO DEVIATIONS, NON-CONFORMANCES, OR REWORKS WERE OBSERVED. THE RETAIN TEST STRIPS WERE TESTED AND THEY PASSED TESTING WITH NO FAULTS FOUND. LIFESCAN (LFS) HAS REQUESTED THE RETURN OF THE TEST STRIPS FOR EVALUATION. IF THE TEST STRIPS ARE RETURNED LFS WILL EVALUATE THEM AND INFORM FDA OF THOSE FINDINGS IN A SUPPLEMENTAL REPORT. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE LAY USER/PATIENT'S PRODUCT(S) HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: THE TEST STRIPS INVOLVED WITH THIS COMPLAINT WERE TESTED AND FOUND TO HAVE FAILED FOR CONTROL SOLUTION. IN ADDITION, THERE WAS AN ERROR 4 ISSUE. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT IN (B)(4) CONTACTED LIFESCAN TO REPORT THE ONE TOUCH VERIO METER WAS GIVING INACCURATE READINGS. THE SR. MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION ORIGINALLY PROVIDED. ON (B)(6) 2011 AT 4:30 PM, THE PATIENT OBTAINED THE BLOOD GLUCOSE READING OF 18.7 MMOL/L (337 MG/DL) ON THE REPORTED METER WITH A NEWLY OPENED BOX OF TEST STRIPS. BASED ON THIS ELEVATED READING, THE PATIENT TOOK SIX UNITS NOVORAPID INSULIN. UPON RETURNING HOME, AT A TIME PERIOD GREATER THAN 20 MINUTES, THE PATIENT RETESTED HIS BLOOD GLUCOSE LEVEL USING A DIFFERENT VIAL OF TEST STRIPS AND OBTAINED THE READING OF 2.7 MMOL/L (49 MG/DL). AT THAT TIME, THE PATIENT EXPERIENCED THE SYMPTOMS OF HUNGER AND YAWNING. AT 6:15 PM, THE PATIENT ADMINISTERED SELF-TREATMENT WITH FOOD; HE DID NOT SEEK MEDICAL ATTENTION. THE METER AND TEST STRIPS WERE REPLACED. THE PATIENT ALLEGEDLY SUFFERED BLOOD GLUCOSE LEVELS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER TAKING AN INSULIN DOSE BASED ON AN ELEVATED METER READING, AND RECEIVED TREATMENT WITH FOOD. THEREFORE, THIS COMPLAINT IS BEING REPORTED.

    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 3167983

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Life Threatening| R