BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3020476 · Received March 26, 2013

    Report

    Report Number
    3008382007-2013-06259
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Report Date
    March 12, 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 # 1 ¿ (6/20/2013)THE PATIENT¿S METER AND TEST STRIPS HAVE BEEN RETURNED ON 5/31/2013 AND 6/6/2013, RESPECTIVELY, AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 6/11/2013 WITH THE FOLLOWING FINDINGS:THE METER INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE METER WAS FOUND TO BE UNABLE TO REPRODUCE AN ERROR 2 SC 1 MESSAGE. THE TEST STRIPS INVOLVED WITH THIS COMPLAINT PASSED TESTING. THE TEST STRIPS WERE EVALUATED AND THE PRIMARY COMPLAINT WAS NOT CONFIRMED; HOWEVER, A SECONDARY ISSUE WAS NOTED WHERE ERROR 4 WAS OBSERVED DURING CONTROL SOLUTION TESTS.IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A FOLLOW UP REPORT. 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 WOULD INTERMITTENTLY DISPLAY AN "ERROR 2" MESSAGE. PER THE OWNER'S BOOKLET THIS MESSAGE COULD BE CAUSED EITHER BY A USED TEST STRIP OR A PROBLEM WITH THE METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED ERROR MESSAGE BEGAN APPEARING INTERMITTENTLY SINCE HE STARTED USING THE SUBJECT METER APPROXIMATELY 1 YEAR AGO. THE PATIENT INFORMED THE CSR THAT HE MANAGES HIS DIABETES WITH A COMBINATION OF INSULIN AND ORAL MEDICATION(S). THE PATIENT DENIED TAKING ANY ACTION REGARDING HIS USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED METER ISSUE. THE PATIENT ALSO DENIED DEVELOPING SYMPTOMS, BUT MENTIONED TREATING SELF WITH 8 UNITS OF HUMULIN ON (B)(6) 2013 AT MIDNIGHT. THE PATIENT ALSO MENTIONED OBTAINING A BLOOD GLUCOSE READING OF "11.2 MMOL/L" ON ANOTHER DEVICE ON (B)(6) 2013 AT 10:30 AM. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THAT ERROR 2 DID NOT APPEAR WHEN THE SUBJECT METER WAS MANUALLY POWERED ON. THE ALLEGED METER ISSUE REMAINED UNRESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. 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 AS A MALFUNCTION BECAUSE THE ALLEGED METER ISSUE REMAINED UNRESOLVED AT THE TIME OF TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124062 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3233897

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR