BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3093211 · Received May 4, 2013

    Report

    Report Number
    3008382007-2013-10219
    Event Type
    Malfunction
    Date Received
    May 4, 2013
    Report Date
    April 18, 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

    FOLLOW-UP # 2 ¿ (08/01/2013) THE PATIENT¿S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2013 AND (B)(4) 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 (6/16/2013)-DEVICE EVALUATION: THE TEST STRIPS INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 5/22/2013 WITH THE FOLLOWING FINDINGS: THE TEST STRIP HAS PASSED 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

    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) 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 ON (B)(6) 2013 AT APPROXIMATELY 5PM HE DEVELOPED SYMPTOMS OF "FEELING SWEATY AND TIRED." AT THE ONSET OF SYMPTOMS, THE PATIENT CLAIMED HE IMMEDIATELY TESTED HIS BLOOD GLUCOSE AND OBTAINED BLOOD GLUCOSE READINGS OF "4.7 MMOL/L (85 MG/DL)" WITH THE SUBJECT METER AND "2.7 MMOL/L (49 MG/DL)" ON ANOTHER DEVICE (CONTOUR METER), PERFORMED WITHIN A FEW 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 MG/DL. THE PATIENT REPORTED TREATING HIMSELF WITH FOOD AND/OR DRINK IN RESPONSE TO THE SYMPTOMS AND LOW RESULT OBTAINED ON THE OTHER DEVICE. DURING THE FOLLOW-UP CALL, THE PATIENT INFORMED THE CSR THAT HE USUALLY TESTS HIS BLOOD GLUCOSE ONCE A DAY AND TAKES ORAL MEDICATIONS (METFORMIN AND GLYBURIDE) TO MANAGE HIS DIABETES. PRIOR TO ONSET OF SYMPTOMS ON (B)(6) 2013, THE PATIENT REPORTED THAT HE HAD LAST TESTED WITH THE SUBJECT METER EITHER ON (B)(6) 2013 AND DID NOT RECALL WHAT THE RESULT WAS. AT THE TIME OF TROUBLESHOOTING, THE PATIENT CONFIRMED HE WAS USING TEST STRIPS THAT WERE NOT EXPIRED OR OPENED PAST THEIR DISCARD DATE. THE PATIENT DID NOT HAVE CONTROL SOLUTION AVAILABLE TO TEST THE SUBJECT METER. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. ALTHOUGH THE PATIENT DEVELOPED SIGNS/SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY, THERE IS NO INDICATION THAT THE SUBJECT METER CAUSED OR CONTRIBUTED TO THIS EVENT. THE PATIENT WAS SYMPTOMATIC PRIOR TO OBTAINING THE ALLEGED INACCURATE HIGH READING. HOWEVER, THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION BECAUSE THE SUBJECT METER DID NOT MEET LFS ACCURACY CRITERIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195790 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3423380

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR