BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 4282830 · Received November 27, 2014

    Report

    Report Number
    2939301-2014-32377
    Event Type
    Injury
    Date Received
    November 27, 2014
    Report Date
    November 17, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K073231
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT METER WAS RETUNED ON (B)(4) AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4), 2014. THE METER PASSED ALL TESTING WITH NO FAULTS FOUND, THE PRIMARY COMPLAINT WAS NOT REPRODUCED. THE TEST STRIPS HAVE NOT YET BEEN RETURNED TO LFS. IF THE PRODUCTS ARE RETURNED, LFS WILL EVALUATE THEM AND INFORM FDA OF PRODUCTS THAT DO NOT PASS IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (12/26/2014). THE PATIENT¿S TEST STRIPS HAVE BEEN RETURNED ON 12/15/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 12/15/2014 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) 2014 THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING MULTIPLE INACCURACIES ON THEIR ONETOUCH ULTRALINK METER. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT WAS UNABLE TO PROVIDE DETAILS OF WHEN THE ALLEGED INACCURACY BEGAN. THE PATIENT REPORTED OBTAINING BLOOD GLUCOSE READINGS OF ¿241, 168, 470, 42, 370, 44MG/DL AND HIGH¿ ON THE SUBJECT METER AND ALLEGED THAT THESE READINGS WERE INACCURATELY HIGH COMPARED TO THEIR FEELINGS AND/OR NORMAL RESULTS. THE DATES AND TIMES OF THESE READINGS ARE UNKNOWN. THE PATIENT MANAGES THEIR DIABETES WITH AN INSULIN PUMP AND THE PATIENT REPORTED CONSUMING LESS FOOD AND DRINK IN RESPONSE TO THE ALLEGED INACCURATE READINGS. THE PATIENT REPORTED DEVELOPING SYMPTOMS OF ¿HARD TO BREATHE, NAUSEA, HARD TO MOVE, TIGHTNESS IN CHEST AND TASTE IN MOUTH FROM HAVING HIGH BLOOD SUGAR¿. THE PATIENT REPORTED DEVELOPING THESE SYMPTOMS BEFORE THE PRODUCT ISSUE BEGAN BUT COULD NOT RECALL EXACTLY WHEN. THE PATIENT REPORTED HAVING THEIR BLOOD GLUCOSE TESTED ON AN EMERGENCY SERVICES METER ON (B)(6) 2014, AND REPORTED READINGS OF ¿30MG/DL¿ AT 1PM AND ¿147MG/DL¿ AT 1:30PM. THE PATIENT REPORTED BEING TREATED BY AN HCP WITH IV GLUCOSE AT 1PM. AT THE TIME OF TROUBLESHOOTING THE CCA VERIFIED THAT THE UNIT OF MEASURE WAS SET CORRECTLY AND THAT THE TEST STRIPS WERE STORED CORRECTLY (PER OWNER¿S BOOKLET RECOMMENDATION). THE PATIENT DID NOT HAVE CONTROL SOLUTION AVAILABLE TO TEST THE SUBJECT METER. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT WAS TREATED BY AN HCP FOR SEVERE HYPOGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770744 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3576653

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Life Threatening| R