BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3131962 · Received May 29, 2013

    Report

    Report Number
    3008382007-2013-13047
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    May 1, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Removal / Correction Number
    2013-IE-017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    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) USA, ALLEGING THAT THE ONETOUCH VERIO IQ METER IS GIVING INACCURATE HIGH READING OF 390, 360, AND 375 MG/DL COMPARED A METER READING OF 275 MG/DL. THIS COMPLAINT IS CLASSIFIED ACCORDING TO THE DOCUMENTATION OF THE CUSTOMER CARE ADVOCATE AND THE FOLLOW-UP INFORMATION OBTAINED ON (B)(6) 2013. THE PATIENT MANAGES HER BLOOD GLUCOSE WITH INSULIN BASED ON A SLIDING SCALE. THE ELEVATED READINGS BEGAN ON (B)(6) 2013. THE PATIENT CLAIMED THAT SHE HAD SYMPTOMS DESCRIBED AS ¿FELT HOT, WEAK, AND SWEATY¿ 5-10 MINUTES PRIOR TO THE ONSET OF THE ELEVATED READINGS. ACCORDING TO THE PATIENT, THE AFOREMENTIONED SYMPTOMS WERE INDICATIVE OF HAVING HIGH BLOOD GLUCOSE. SHE WAS ABLE TO ADMINISTERED SELF TREATMENT WITH 10 UNITS INSULIN AT THE TIME OF CONCERN. THE SYMPTOMS ABATED WITH 20 MINUTES OF TREATMENT. THERE WAS NO REPORT OF ANY REQUIRED HCP TREATMENT TO SUGGEST A SERIOUS INJURY AT THE TIME OF CONCERN. DURING TROUBLESHOOTING, THE PATIENT VERIFIED THE READINGS WERE PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS LIFESCAN¿S CRITERIA FOR ACCURACY. THE UNIT OF MEASUREMENT WAS CORRECTLY SET. THE PATIENT WAS USING THE CORRECT TECHNIQUE PER THE INSTRUCTION FOR USE. THE UNIT OF MEASUREMENT WAS SET ACCORDINGLY. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGED INACCURATE HIGH ISSUE. THERE IS NO EVIDENCE THE PATIENT SUFFERED A SERIOUS INJURY DUE TO THE LFS METER. THE HYPERGLYCEMIC LFS METER READINGS CORRELATED WITH THE ALLEGED HYPERGLYCEMIC SYMPTOMS AND TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236096 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3418735

    Patients

    Seq Age Sex Outcome Treatment
    1