BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO TEST STRIPS

    MDR report key: 3071097 · Received April 22, 2013

    Report

    Report Number
    3008382007-2013-08555
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Report Date
    April 10, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K093745
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    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 #1 ((B)(4) 2013)-DEVICE EVALUATION: THE TEST STRIPS INVOLVED WITH THIS COMPLAINT HAVE BEEN RETURNED TO LFS AND EVALUATED BY PRODUCT ANALYSIS (PA) ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE TEST STRIPS PASSED ALL TESTING WITH NO FAULTS FOUND. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, ANOTHER FOLLOW UP REPORT WILL BE SUBMITTED. 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 A PROBLEM WITH ONETOUCH VERIO TEST STRIP(S) SHE WAS USING. THE PATIENT REPORTED THAT THE FORK END OF THE TEST STRIP WAS BENDING UPON INSERTING INTO THE METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED STRIP ISSUE OCCURRED APPROXIMATELY 2 WEEKS PRIOR TO CONTACTING LFS. PRIOR TO WHEN THE ALLEGED STRIP ISSUE WAS NOTICED, THE PATIENT CLAIMED SHE BEGAN TO FEEL DIZZY AND A LITTLE SHAKY. IN RESPONSE TO HER SYMPTOMS SHE IMMEDIATELY ATTEMPTED TO TEST WITH HER ONETOUCH ULTRASMART METER; HOWEVER, WAS UNABLE TO GET A READING BECAUSE IT DID NOT POWER ON. THE PATIENT THEN ATTEMPTED TO TEST WITH HER ONETOUCH VERIOIQ METER AND CLAIMED AFTER TROUBLE WITH STRIP INSERTION AND WASTING STRIPS SHE WAS FINALLY ABLE TO TEST SUCCESSFULLY AND OBTAINED A READING OF "2.2 MMOL/L". IN RESPONSE TO THE SYMPTOMS, THE PATIENT CLAIMED SHE TREATED HERSELF WITH GLUCOSE TABLETS. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THAT THE PATIENT DECLINED TO TROUBLESHOOT THE ALLEGED STRIP ISSUE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. ALTHOUGH THE PATIENT DEVELOPED SIGNS/SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA, THERE IS NO INDICATION THAT THE ALLEGED STRIP ISSUE CAUSED OR CONTRIBUTED TO THIS SERIOUS INJURY. THE PATIENT WAS ALREADY SYMPTOMATIC WHEN THE ALLEGED STRIP ISSUE BEGAN. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED STRIP ISSUE REMAINED UNRESOLVED AT THE TIME OF TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171560 OT VERIO TEST STRIPS GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3362692

    Patients

    Seq Age Sex Outcome Treatment
    1