BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3102136 · Received May 9, 2013

    Report

    Report Number
    3008382007-2013-10762
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Report Date
    April 26, 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
    CA
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (07/05/2013). THE PATIENT¿S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 5/29/2013 AND 6/28/2013, RESPECTIVELY, 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 # 1 ¿ (6/15/2013). THE PATIENT¿S TEST STRIPS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 5/15/2013 AND 6/3/2013, RESPECTIVELY, 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) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THAT HIS ONETOUCH VERIOIQ METER READ INACCURATELY HIGH COMPARED TO ANOTHER DEVICE. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DURING A FOLLOW-UP CALL WITH THE PATIENT. THE PATIENT REPORTED THAT APPROXIMATELY 1 WEEK PRIOR TO CONTACTING LFS HE HAD OBTAINED BLOOD GLUCOSE READINGS OF "7.0 MMOL/L (126 MG/DL)" WITH THE SUBJECT METER AND "2.7 MMOL/L (49 MG/DL)" ON ANOTHER DEVICE (CONTOUR METER), PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF (B)(4). THE PATIENT REPORTED THAT PRIOR TO TESTING ON BOTH DEVICES HE HAD DEVELOPED SYMPTOMS OF "SHAKY AND STRESS" WHICH HE ASSOCIATED WITH A LOW BLOOD GLUCOSE. IT IS NOT CLEAR HOW MUCH TIME ELAPSED BETWEEN ONSET OF SYMPTOMS AND WHEN HE TESTED WITH BOTH DEVICES. DURING THE INITIAL CALL TO LFS, THE PATIENT REPORTED HE HAD DEVELOPED THE SYMPTOMS ½ HOUR PRIOR; HOWEVER, DURING THE FOLLOW-UP CALL HE CLAIMED HE TESTED WITH BOTH METERS 2 HOURS AND 45 MINUTES AFTER THE ONSET OF SYMPTOMS. IN RESPONSE TO THE SYMPTOMS, THE PATIENT REPORTED THAT HE TREATED HIMSELF WITH A SWEET CARAMEL DRINK AND CONFIRMED FEELING BETTER AFTERWARDS. PRIOR TO THE ONSET OF SYMPTOMS, THE PATIENT INFORMED THE CSR THAT HE HAD TESTED WITH THE SUBJECT METER 4 HOURS PRIOR, BUT DID NOT RECALL THE READING OBTAINED. THE PATIENT MENTIONED THAT HE DID NOT REMEMBER THE RESULT BEING "ALARMING". THE PATIENT DENIED MAKING ANY CHANGES TO HIS USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE READING. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THAT THE PATIENT WAS USING THE CORRECT TESTING TECHNIQUE. THE PATIENT CONFIRMED THE TEST STRIPS WERE NOT PAST THEIR EXPIRATION DATE OR OPENED PAST THEIR DISCARD DATE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. ALTHOUGH THE PATIENT DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA, THERE IS NO INDICATION THAT THE REPORTED ISSUE CAUSED OR CONTRIBUTED TO THIS SERIOUS INJURY. THE PATIENT WAS SYMPTOMATIC PRIOR TO OBTAINING THE ALLEGED INACCURATE READING WITH THE SUBJECT METER. 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
    203579 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR