BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 2931269 · Received January 28, 2013

    Report

    Report Number
    3008382007-2013-01663
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Report Date
    January 17, 2013
    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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP ((B)(4) 2013)-DEVICE EVALUATION: THE METER AND TEST STRIPS INVOLVED WITH THIS COMPLAINT HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2013 RESPECTIVELY WITH THE FOLLOWING FINDINGS: THE METER AND TEST STRIPS PASSED ALL TESTING WITH NO FAULTS FOUND. THE ERROR 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. DEVICE RETURNED TO MFG DATE: METER- (B)(4) 2013, TEST STRIPS- (B)(4) 2013.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THAT HER ONETOUCH VERIO IQ METER READ INACCURATELY LOW COMPARED TO ANOTHER DEVICE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT REPORTED THAT ON THE EVENING OF (B)(6) 2013 SHE DEVELOPED SYMPTOMS OF "SWEATY AND SHAKY", WHICH SHE ASSOCIATED WITH A HIGH BLOOD GLUCOSE. AT THE ONSET OF SYMPTOMS, THE PATIENT CLAIMED SHE IMMEDIATELY TESTED HER BLOOD GLUCOSE AND OBTAINED READINGS OF "7.0 MMOL/L" WITH THE SUBJECT METER AND "14.0 MMOL/L" ON ANOTHER DEVICE, PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF LESS THAN OR EQUAL TO 30%. THE PATIENT INFORMED THE CSR THAT THE FELT THE READING OF "14.0 MMOL/L" WAS CORRECT BECAUSE, SHE WAS TAKING STEROIDS FOR LUNG DISEASE WHICH USUALLY CAUSED HER BLOOD GLUCOSE TO INCREASE. IN RESPONSE TO THE SYMPTOMS AND ELEVATED BLOOD GLUCOSE READING OBTAINED ON THE OTHER DEVICE, THE PATIENT REPORTED TAKING A "GLUCONORM TABLET" TO BRING HER SUGAR LEVEL DOWN. THE PATIENT INFORMED THE CSR THAT SHE GENERALLY MANAGES HER DIABETES WITH DIET AND EXERCISE AND DOES NOT TAKE ANY MEDICATIONS. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THAT THE PATIENT DID NOT HAVE CONTROL SOLUTION AVAILABLE TO TEST THE SUBJECT METER AND TEST STRIPS. REPLACEMENT PRODUCT WAS SENT TO THE PATIENT. ALTHOUGH, THE PATIENT DEVELOPED SYMPTOMS, SHE ASSOCIATED WITH HYPERGLYCEMIA, THERE IS NO INDICATION THAT THE ALLEGED METER ISSUE CAUSED AND/OR CONTRIBUTED TO THIS INJURY. THE PATIENT REPORTED THAT HER ELEVATED BLOOD GLUCOSE WAS DUE TO TAKING STEROIDS FOR A HEALTH CONDITION UNRELATED TO HER DIABETES. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE, THE SUBJECT METER DID NOT MEET LFS' ACCURACY CRITERIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36541 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3396978

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR