BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3084284 · Received April 30, 2013

    Report

    Report Number
    3008382007-2013-09571
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Report Date
    April 5, 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
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (10/28/2013). THE PATIENT¿S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 9/25/2013 AND 10/18/2013, 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

    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 THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED METER INACCURACY BEGAN IN MID TO LATE FEBRUARY 2013. THE PATIENT REPORTED OBTAINING INACCURATE HIGH READINGS IN THE "300 TO 400 MG/DL RANGE" WITH THE SUBJECT METER ON UNSPECIFIED DATES/TIMES. THE PATIENT ALSO CLAIMED OBTAINING BLOOD GLUCOSE READINGS OF "199, 132, 145, 166, 304, 219, 98 AND 117 MG/DL" ON ANOTHER DEVICE (PRECISION EXTRA) ON UNSPECIFIED DATES/TIMES. THE PATIENT INFORMED THE CCA THAT HE DID PERFORM TESTS ON BOTH DEVICES WITHIN 30 MINUTES OF EACH OTHER; HOWEVER, THE SPECIFIC RESULTS OBTAINED ON BOTH METERS AT THE TIME HE PERFORMED THE METER TO OTHER METER COMPARISON WERE NOT PROVIDED. THE PATIENT INFORMED THE CCA THAT HE MANAGES HIS DIABETES WITH INSULIN AND CONFIRMED HE CONTINUED HIS USUAL DIABETES MANAGEMENT REGIMEN DESPITE OBTAINING THE ELEVATED RESULTS WITH THE SUBJECT METER. THE PATIENT DENIED DEVELOPING SYMPTOMS, BUT CLAIMED SEEING HIS HCP ON (B)(6) 2013 AND/OR (B)(6) 2013 AND BEING ADVISED TO STOP USING THE SUBJECT METER. THE PATIENT ALSO MENTIONED THAT HIS HCP GAVE HIM AN "INSULIN EMERGENCY PEN". AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT METER WAS NOT CHARGED AND THEREFORE A CONTROL SOLUTION TEST COULD NOT BE PERFORMED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT THE SUBJECT METER CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT DID NOT DEVELOP SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA OR HYPERGLYCEMIA, NOR RECEIVE MEDICAL INTERVENTION FOR EITHER OF THESE CONDITIONS. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE SUBJECT METER POTENTIALLY DID NOT MEET LFS' ACCURACY CRITERIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186202 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3303961

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR