BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3771975 · Received April 25, 2014

    Report

    Report Number
    2939301-2014-09627
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Report Date
    April 18, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 ¿ (09/10/2014). THE LAY USER/PATIENT¿S METER HAS BEEN RETURNED ON 08/20/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 09/06/2014 WITH THE FOLLOWING FINDINGS:THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 2 ¿ (10/11/2014). THE PATIENT¿S TEST STRIPS HAVE BEEN RETURNED ON 9/9/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 10/2/2014 WITH THE FOLLOWING FINDINGS: THE TEST STRIPS PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE CONFIRMED. 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) 2014, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH VERIOIQ METER WAS READING INACCURATELY HIGH. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE¿S (CCA) DOCUMENTATION. THE PATIENT CLAIMED THE ALLEGED ISSUE OVER THE PAST SEVERAL MONTHS. THE PATIENT REPORTEDLY TESTED ON THE SUBJECT METER AND OBSERVED VALUES OF ¿250, 178, 230, AND 150MG/DL¿ AS COMPARED TO READINGS OBTAINED WITH ANOTHER DEVICE THAT READ ¿185, 135, 150, AND 122MG/DL.¿ EACH COMPARISON WAS MADE WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 30% AND/OR <= 30 MG/DL. THE PATIENT MANAGES HIS DIABETES WITH NOVOLOG INSULIN AND IS A SELF-ADJUSTER. HE STATED THAT HE INCREASED HIS INSULIN DOSE BY AN UNKNOWN AMOUNT IN RESPONSE TO THE HIGHER READINGS SEVERAL TIMES OVER THE PAST MONTH. THE PATIENT CLAIMED THAT HE DEVELOPED SYMPTOMS OF ¿LOW BLOOD GLUCOSE, IRRITABILITY AND NUMBNESS¿ APPROXIMATELY 1-2 HOURS LATER. NO FORM OF MEDICAL INTERVENTION WAS RECEIVED. AT THE TIME OF TROUBLESHOOTING THE CCA CONFIRMED THE METER WAS SET TO THE CORRECT UNIT OF MEASURE, THE SUBJECT TEST STRIPS WERE IN GOOD CONDITION. A CONTROL SOLUTION TEST WAS NOT PERFORMED BECAUSE THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION AVAILABLE. REPLACEMENT PRODUCTS HAVE BEEN SENT TO THE PATIENT AND SUBJECT PRODUCTS ARE PENDING RETURN FOR INVESTIGATION. BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT THE REPORTED ISSUE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY SINCE THE PATIENT SYMPTOMS DID NOT CORRELATE WITH LFS¿S DEFINITION SUGGESTIVE OF SEVERE HYPOGLYCEMIA OR HYPERGLYCEMIA, NOR DID HE RECEIVE MEDICAL INTERVENTION FOR EITHER OF THESE CONDITIONS. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED PRODUCT ISSUE REMAINED UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251816 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3572845

    Patients

    Seq Age Sex Outcome Treatment
    1