BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 5147034 · Received October 14, 2015

    Report

    Report Number
    2939301-2015-43734
    Event Type
    Injury
    Date Received
    October 14, 2015
    Date of Event
    October 7, 2015
    Report Date
    October 8, 2015
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #2: THE RETAIN TEST STRIPS HAVE BEEN FURTHER EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: ALTHOUGH IT WAS PREVIOUSLY REPORTED THAT THE RETAIN TEST STRIPS FAILED PERFORMANCE TESTING WITH BLOOD, THE EVALUATION HAS CONCLUDED THAT THE RETAIN TEST STRIPS PASSED ALL TESTING WITH NO FAULTS FOUND. IN ADDITION, A DEVICE HISTORY RECORD REVIEW WAS ALSO PERFORMED ON THE SUBJECT METER LOT. THE REVIEW DID NOT IDENTIFY ANYTHING THAT COULD ADVERSELY IMPACT PRODUCT PERFORMANCE OR FUNCTION. 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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1. THE RETAIN TEST STRIPS FAILED PERFORMANCE TESTING WITH BLOOD. 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 OCTOBER 8, 2015, THE LAY USER/PATIENT CONTACTED LIFESCAN USA ALLEGING THAT HIS ONETOUCH ULTRA2 METER READ INACCURATELY ERRATIC. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT STATED THAT THE ALLEGED PRODUCT ISSUE BEGAN ON (B)(6) 2015 AT 9:23 PM. THE PATIENT STATED THAT HE OBTAINED THE RESULTS OF "191, 257, 133 AND 130 MG/DL" USING THE SUBJECT METER, THE RESULTS WERE TAKEN MORE THAN 20 MINUTES APART FROM EACH OTHER. THE PATIENT MANAGES HIS DIABETES WITH SELF-ADJUSTING INSULIN. THE PATIENT STATED THAT HE TOOK MORE FOOD/DRINK ON THE NIGHT OF (B)(6) 2015 (TIME NOT PROVIDED) IN RESPONSE TO THE ALLEGED PRODUCT ISSUE. THE PATIENT CLAIMED TO HAVE DEVELOPED THE SYMPTOM OF "BROKE INTO A SWEAT" APPROXIMATELY 30 MINUTES AFTER THE ALLEGED PRODUCT ISSUE BEGAN; HOWEVER HE DENIED THAT HE RECEIVED ANY TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THAT THE PATIENT WAS USING AN APPROVED SAMPLE SITE AND THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE SETTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED THE SYMPTOM OF "BROKE INTO A SWEAT" 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
    678045 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3853126

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Life Threatening