BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 4161092 · Received October 10, 2014

    Report

    Report Number
    2939301-2014-27082
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Report Date
    October 4, 2014
    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
    NY, 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 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) 2014, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH VERIO IQ METER DISPLAYED AN ¿APPLY SAMPLE¿ MESSAGE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION AS MEDICAL SURVEILLANCE WAS UNABLE TO REACH TO PATIENT TO OBTAIN ADDITIONAL INFORMATION. THE PATIENT ALLEGED THAT ¿A COUPLE OF WEEKS¿ PRIOR TO CONTACTING LFS, AT 04:00AM, THE SUBJECT METER DISPLAYED AN ¿APPLY SAMPLE¿ MESSAGE. THE PATIENT DETAILED THAT HER DIABETES IS USUALLY MANAGED WITH A COMBINATION OF ORAL MEDICATION, DIET AND EXERCISE AND DENIED THAT SHE TOOK ANY ACTION REGARDING HER USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE METER MESSAGE. THE PATIENT REPORTED THAT AT AN UNKNOWN TIME AFTER THE METER ISSUE OCCURRED SHE ALLEGEDLY DEVELOPED A SYMPTOM OF ¿CRAMPS IN HER LEG¿ AND THAT ¿ONE WEEK¿ PRIOR TO CONTACTING LFS, SHE HAD A DOCTOR¿S OFFICE VISIT WHERE SHE WAS GIVEN GLIPIZIDE 10MG. THE PATIENT ALSO DETAILED THAT ON (B)(6) 2014, AT 04:30PM, SHE OBTAINED A BLOOD GLUCOSE READING OF ¿344MG/DL¿ ON A CLINIC METER. THE CCA NOTED THAT IT WAS THE FIRST TIME THAT THE PRODUCT HAD BEEN USED AND THE CORRECT TESTING STRIPS HAD BEEN USED, BUT THAT THE PATIENT DID NOT HAVE TESTING SUPPLIES AVAILABLE TO WALK THROUGH A RETEST. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION THE PRODUCT ISSUE CAUSED AND/OR CONTRIBUTED TO AN ADVERSE EVENT. THE PATIENT¿S REPORTED SYMPTOM OF ¿CRAMPS IN THE LEG¿ DOES NOT MEET LIFESCAN'S CRITERIA FOR A SERIOUS INJURY. THE PATIENT DID NOT RECEIVE ANY TREATMENT FROM A HEALTHCARE PROFESSIONAL FOR AN ACUTE BLOOD GLUCOSE EXCURSION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642532 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR