BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 5112847 · Received September 30, 2015

    Report

    Report Number
    2939301-2015-41293
    Event Type
    Injury
    Date Received
    September 30, 2015
    Date of Event
    September 17, 2015
    Report Date
    September 21, 2015
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 3: 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. A DHR (DEVICE HISTORY RECORD) WAS COMPLETED FOR THIS PRODUCT AND NO DEVIATIONS, NON-CONFORMANCES, OR REWORKS WERE OBSERVED. 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

    FOLLOW-UP # 2 THE LAY USER/PATIENT¿S CONTROL SOLUTION HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE CONTROL SOLUTION PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE CONFIRMED. IN ADDITION, THE LAY USER/PATIENTS TEST STRIPS HAVE BEEN FURTHER EVALUATED BY PRODUCT ANALYSIS AND THE VIAL WAS FOUND TO HAVE BEEN EXPOSED TO MOISTURE. THE ADDITIONAL TESTS PERFORMED ON THE TEST STRIP VIAL AND THE DESICCANT WERE TO CHECK THE STRUCTURAL INTEGRITY AND FOR A POSSIBLE MOISTURE ISSUE. THE STRUCTURAL INTEGRITY OF THE TEST STRIP VIAL WAS FOUND TO BE INTACT DURING A GROSS LEAK TEST. THE DESICCANT WITHIN THE SUBJECT VIAL WAS FOUND TO CONTAIN MORE MOISTURE THAN EXPECTED FROM NORMAL USE (AS PER PRODUCT LABELLING). 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

    THE TEST STRIPS INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE REPORTED ISSUE WAS CONFIRMED. ADDITIONAL TESTS WERE PERFORMED ON THE TEST STRIP VIAL AND THE DESICCANT; THESE TESTS PASSED AND FAILED RESPECTIVELY. IN ADDITION, PERFORMANCE TESTING WITH BLOOD WAS PERFORMED ON THE RETAIN TEST STRIPS. THE RETAIN TEST STRIPS PASSED ALL TESTING. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH VERIOIQ METER DISPLAYED INACCURATELY HIGH RESULTS COMPARED TO HER FEELINGS/NORMAL RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT CLAIMED THAT THE SUBJECT METER STARTED READING INACCURATELY COMPARED TO HER FEELINGS ON (B)(6) 2015 AT 5:09AM, ALTHOUGH NO RESULTS WERE PROVIDED FOR THIS TIME. SHE CLAIMED THAT ON (B)(6) 2015 AT 8:39AM, SHE OBTAINED ALLEGED INACCURATELY HIGH BLOOD GLUCOSE RESULTS OF 190, 206, 229 AND 195 MG/DL ON THE SUBJECT METER. METER TO FEELINGS/NORMAL RESULTS COMPARISONS DO NOT MEET THE CRITERIA NECESSARY FOR LFS TO DETERMINE AN INACCURACY. THE PATIENT MANAGES HER DIABETES WITH ORAL MEDICATION, DIET AND/OR EXERCISE. IT IS UNCLEAR WHAT ACTION, IF ANY, SHE TOOK AFTER OBTAINING THE ALLEGED INACCURATE RESULTS. SHE CLAIMED THAT ONE DAY LATER, ON (B)(6) 2015 SHE DEVELOPED SYMPTOMS OF HEADACHE, NAUSEA, UPSET STOMACH [AND] DIARRHEA AND THAT THE EMERGENCY MEDICAL SERVICES (EMS) WAS CONTACTED. SHE CLAIMED THAT AT 7:00AM ON (B)(6) 2015 SHE RECEIVED TREATMENT OF IV FLUIDS FROM A HEALTHCARE PROFESSIONAL (HCP) FOR HER SYMPTOMS. SHE ALSO CLAIMED THAT AT AN UNKNOWN TIME, A BLOOD GLUCOSE RESULT OF 126 MG/DL WAS OBTAINED ON THE EMS METER AND ALL DAY ON (B)(6) 2015 SHE CONSUMED LESS FOOD/DRINK. DURING TROUBLESHOOTING, THE CCA ESTABLISHED THAT PATIENT'S TEST STRIPS HAD BEEN STORED CORRECTLY AND THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE. THE CCA WALKED THE PATIENT THROUGH A CONTROL SOLUTION TEST AND THE RESULT FELL OUTSIDE THE RANGE EXPECTED. 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 AND REPORTEDLY RECEIVED TREATMENT FOR SEVERE HYPOGLYCEMIA FROM AN HCP AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643831 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3798749

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R