BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO2 METER

    MDR report key: 5941637 · Received September 10, 2016

    Report

    Report Number
    3008382007-2016-46842
    Event Type
    Malfunction
    Date Received
    September 10, 2016
    Report Date
    August 31, 2016
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K131363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HIS ONETOUCH VERIO2 METER WAS READING BLOOD SAMPLES AS CONTROL SOLUTION. THE COMPLAINT WAS CLASSIFIED BASED ON CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT WAS UNABLE TO SPECIFY WHEN THE ALLEGED ISSUE BEGAN. THE PATIENT ADVISED THE CSR THAT HE DOES NOT TAKE ANY MEDICATION TO MANAGE HIS DIABETES. THE PATIENT CLAIMED THAT HE TESTED HIS BLOOD GLUCOSE WITH THE SUBJECT METER AND OBTAINED RESULTS OF "191, 161 AND 147 MG/DL" WHICH THE METER FLAGGED AS CONTROL SOLUTION TESTS. HE CLAIMED THAT AN UNKNOWN TIME PRIOR TO THE ALLEGED ISSUE, HE DEVELOPED SYMPTOMS OF FEELING "DIZZY" AND THAT HIS "FACE TURNED RED." IN RESPONSE TO THESE SYMPTOMS, HE SELF-TREATED WITH FOOD/AND OR DRINK. THE PATIENT DENIED RECEIVING MEDICAL TREATMENT AS A RESULT OF THE ALLEGED ISSUE. AT THE TIME OF TROUBLESHOOTING, THE CSR WALKED THROUGH A RE-TEST WITH THE PATIENT AND THE ALLEGED ISSUE WAS NOT RESOLVED. THE CSR CONFIRMED THAT THE TEST STRIP VIAL WAS INTACT, THAT THE TEST STRIPS HAD BEEN STORED PROPERLY, WERE NOT OPEN PAST THEIR DISCARD DATE AND HAD NOT EXPIRED. IT WAS ALSO NOTED BY THE CSR THAT THE CORRECT TESTING METHOD WAS BEING FOLLOWED. THERE WAS NO APPARENT MISUSE OF THE PRODUCT AND REPLACEMENTS 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'S REPORTED SYMPTOMS DO NOT MEET LFS' SERIOUS INJURY CRITERIA, NOR DID HE RECEIVE ANY MEDICAL INTERVENTION DUE TO THE REPORTED ISSUE. FURTHERMORE, THE PATIENT HAD BECOME SYMPTOMATIC PRIOR TO THE ALLEGED METER ISSUE. HOWEVER, THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION BECAUSE THE ALLEGED METER ISSUE WAS NOT RESOLVED DURING TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593362 OT VERIO2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 4027829

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR