BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO PRO METER

    MDR report key: 3101003 · Received May 8, 2013

    Report

    Report Number
    3008382007-2013-10735
    Event Type
    Injury
    Date Received
    May 8, 2013
    Report Date
    May 2, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Removal / Correction Number
    2013-IE-017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING HIS ONETOUCH VERIO PRO METER READ INACCURATELY HIGH. 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 "AROUND 3 WEEKS" PRIOR TO CONTACTING LFS. THE PATIENT REPORTED OBTAINING BLOOD GLUCOSE RESULTS AROUND "520 TO 560 MG/DL" WITH THE SUBJECT METER. THE PATIENT REPORTEDLY DID NOT FEEL HIS BLOOD GLUCOSE WAS THAT HIGH WHICH PROMPTED HIM TO RETEST ON ANOTHER METER. THE PATIENT OBTAINED RESULTS OF "100-130 MG/DL" WITH THE OTHER METER. AROUND THAT SAME TIME FRAME, THE PATIENT ALSO REPORTED OBTAINING ANOTHER "HIGH RESULT" WITH THE SUBJECT METER; HOWEVER, SPECIFIC RESULTS WERE NOT PROVIDED. THE PATIENT MANAGES HIS DIABETES WITH INSULIN. BASED ON THE ALLEGED "UNKNOWN" RESULT, THE PATIENT ADMINISTERED SELF HUMALOG INSULIN (AMOUNT NOT SPECIFIED). ABOUT 1 HOUR AND 20 MINUTES LATER, THE PATIENT CLAIMED HE FELT DIZZY AND "HAD A HYPO." SPECIFIC SYMPTOMS WERE NOT PROVIDED. THE PATIENT ATE A GRAPE SUCKER AS TREATMENT AND FELT BETTER ABOUT 3 HOURS AFTER. THE PATIENT ALLEGED THE ISSUE OCCURRED ON MORE THAN ONE OCCASION. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT. THE CCA WAS NOT ABLE TO WALK THE PATIENT THROUGH QUALITY CONTROL TESTING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS HE OBTAINED AN INACCURATE HIGH READING ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULT, AND 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
    201155 OT VERIO PRO METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Life Threatening| R