BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO PRO METER

    MDR report key: 3200823 · Received July 2, 2013

    Report

    Report Number
    3008382007-2013-18858
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    June 27, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Removal / Correction Number
    2013-IE-017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PATIENT

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, A REPORTER FOR THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THE PATIENT¿S ONETOUCH VERIOPRO METER READ INACCURATELY ERRATIC. THE CUSTOMER CARE ADVOCATE (CCA) WAS UNABLE TO REACH THE LAY USER/ PATIENT FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM LIFESCAN CUSTOMER SERVICE. THE ALLEGED ISSUE BEGAN ¿MONTHS¿ AGO PRIOR TO CONTACTING LFS; HOWEVER, THE PATIENT REPORTEDLY CONTINUED TO TEST WITH THE SUBJECT METER. DAYS PRIOR TO CONTACTING LFS, IT WAS REPORTED THE PATIENT OBTAINED A BLOOD GLUCOSE RESULT OF ¿364 MG/DL¿ WITH THE SUBJECT METER. THE PATIENT MANAGES HIS DIABETES WITH INSULIN (TYPE/ AMOUNT NOT SPECIFIED). IT IS NOT KNOWN IF THE PATIENT MADE CHANGES TO HIS USUAL DOSE OF MEDICATIONS; HOWEVER, AFTER OBTAINING THE ALLEGED RESULT, THE REPORTER GAVE THE PATIENT A GLASS OF WATER WITH SUGAR TO DRINK. ABOUT 2 MINUTES LATER, THE PATIENT RETESTED HIS BLOOD GLUCOSE AND OBTAINED A RESULT OF ¿56 OR 54 MG/DL¿ WITH THE SUBJECT METER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE BACK TO BACK GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <=20% AND/ OR <=20 MG/DL. AT THE TIME OF THE RETEST, THE REPORTER CLAIMED THE PATIENT FELT SYMPTOMS OF DIZZY AND BECAME ¿UNCONSCIOUS.¿ THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM (ER) AND OBTAINED A BLOOD GLUCOSE RESULT OF ¿64 MG/DL¿ WITH THE PHYSICIAN/ HOSPITAL METER. THE PATIENT WAS ADMINISTERED INTRAVENOUS FLUIDS (TYPE NOT CLEAR) FOR ABOUT 20 MINUTES. AFTER, THE PATIENT OBTAINED A BLOOD GLUCOSE RESULT OF ¿380 MG/DL¿ WITH THE PHYSICIAN¿S/ HOSPITAL METER. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT AND AN APPROVED SAMPLE SITE WAS USED FOR TESTING. THE CCA WAS NOT ABLE TO WALK THE REPORTER THROUGH QUALITY CONTROL TESTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE, THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301572 OT VERIO PRO METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Life Threatening| R