BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 5460015 · Received February 25, 2016

    Report

    Report Number
    2939301-2016-08873
    Event Type
    Injury
    Date Received
    February 25, 2016
    Report Date
    February 19, 2016
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 # 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

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

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE LAY USER/PATIENT CONTACTED LIFESCAN USA ALLEGING THAT HIS ONETOUCH ULTRA2 METER READ INACCURATELY HIGH AND ALSO INACCURATELY LOW WHEN TESTED WITH CONTROL SOLUTION. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT WAS UNABLE/UNWILLING TO STATE WHEN THE ALLEGED PRODUCT ISSUE BEGAN. THE PATIENT STATED THAT HE OBTAINED THE RESULT OF "144 MG/DL" USING THE SUBJECT METER COMPARED TO FEELINGS/NORMAL RESULTS. THE PATIENT ALSO STATED THAT HE OBTAINED THE RESULT OF "99 MG/DL" WHEN TESTED WITH CONTROL SOLUTION RANGE OF "113-151 MG/DL". THE PATIENT MANAGES HIS DIABETES WITH ORAL DIABETES MEDICATIONS WITH DIET AND/OR EXERCISE. THE PATIENT STATED THAT HE TOOK MORE FOOD/DRINK IN RESPONSE TO THE ALLEGED PRODUCT ISSUE (DATE/TIME NOT PROVIDED). THE PATIENT CLAIMED TO HAVE DEVELOPED THE SYMPTOM OF "SHAKY" AFTER THE ALLEGED PRODUCT ISSUE BEGAN (DATE/TIME NOT PROVIDED); HOWEVER HE DENIED THAT HE RECEIVED ANY TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THAT THE TEST STRIPS HAD NOT EXPIRED, BEEN OPEN FOR LONGER THAN THE DISCARD DATE OR STORED IMPROPERLY, THE CONTROL SOLUTION HAD NOT EXPIRED OR BEEN OPEN FOR LONGER THAN THE DISCARD DATE, THE TEST STRIP VIAL WAS NOT CRACKED OR BROKEN, THE PATIENT PERFORMED A WALK-THROUGH CONTROL SOLUTION TEST AND THE RESULT WAS NOT IN RANGE, THE PATIENT WAS USING THE CORRECT TESTING TECHNIQUE AND THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE SETTING. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED TO HAVE DEVELOPED THE SYMPTOM OF "SHAKY" AFTER THE ALLEGED PRODUCT ISSUE BEGAN. THIS SYMPTOM DOES MEET LIFESCAN'S CRITERIA FOR A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117657 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3932313

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Life Threatening