BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 5525782 · Received March 25, 2016

    Report

    Report Number
    2939301-2016-14535
    Event Type
    Injury
    Date Received
    March 25, 2016
    Date of Event
    February 24, 2016
    Report Date
    March 14, 2016
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1: THE LAY USER/PATIENTS METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER 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.

    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) ALLEGING THAT HER ONETOUCH VERIOIQ METER DISPLAYED INACCURATELY HIGH RESULTS WHEN TESTED WITH CONTROL SOLUTION. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION AND ADDITIONAL INFORMATION OBTAINED FOLLOWING A REVIEW OF THE CALL. THE PATIENT ALLEGED THAT THE METER STARTED READING INACCURATELY ON THE MORNING OF (B)(6) 2016 WHEN SHE OBTAINED AN ALLEGED INACCURATELY HIGH CONTROL SOLUTION TEST RESULT OF "242 MG/DL" COMPARED TO THE EXPECTED RANGE OF 102-138 MG/DL. THE PATIENT MANAGES HER DIABETES WITH INSULIN (SELF-ADJUSTER). FOLLOWING THE START OF THE ALLEGED ISSUE, THE PATIENT CONTINUED WITH HER USUAL DIABETES MANAGEMENT ROUTINE. SHE CLAIMED THAT 2 WEEKS LATER, AT 6:32AM ON (B)(6) 2016, SHE DEVELOPED SYMPTOMS OF "SHAKY [AND] SWEATING". SHE REPORTED THAT SHE SELF-TREATED HER SYMPTOMS WITH FOOD AND/OR DRINK, ALSO AT 6:32AM ON (B)(6) 2016. THE PATIENT DENIED USING ANY OTHER DEVICE TO TEST HER BLOOD GLUCOSE LEVELS. DURING TROUBLESHOOTING, IT WAS ESTABLISHED THAT THE PATIENT'S METER WAS SET TO THE CORRECT UNIT OF MEASURE, THE PATIENT HAD FOLLOWED THE CORRECT TESTING STEPS AND HAD USED THE CORRECT CONTROL SOLUTION. HOWEVER, THE CCA NOTED THAT THE CONTROL SOLUTION HAD EXPIRED IN FEB 2016. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE OBTAINED INACCURATE HIGH READINGS ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULTS, AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA, AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181780 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Life Threatening| R