BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 3002182 · Received March 13, 2013

    Report

    Report Number
    3008382007-2013-04815
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    February 10, 2013
    Report Date
    February 13, 2013
    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
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT PRODUCTS WERE RETURNED AND PRODUCT ANALYSIS WAS COMPLETED ON THE METER ON (B)(4) 2013, WITH THE FOLLOWING FINDINGS, THE METER PASSED TESTING, THE COMPLAINT WAS NOT REPRODUCED. ON (B)(4) 2013 THE SUBJECT TEST STRIPS WERE TESTED AND PASSED TESTING WITH NO FAULTS FOUND. 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) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS METER WAS READING INACCURATELY LOW. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM LIFESCAN CUSTOMER SERVICE. THE PATIENT CLAIMED THE ALLEGED ISSUE STARTED ON (B)(6) 2013, AT APPROXIMATELY 11PM. HE CLAIMED HE TESTED ON THE SUBJECT DEVICE AND RECEIVED AN INACCURATE LOW READING OF "70MG/DL." BASED ON THE DATA IN THE METER'S MEMORY, THE TEST WAS PERFORMED ON (B)(6) 2013, AT 7AM. IT IS NOT KNOWN WHAT RANGE THE PATIENT CONSIDERS TO BE NORMAL. THE PATIENT MANAGES HIS DIABETES WITH AN UNKNOWN TYPE/DOSE OF INSULIN THROUGH PUMP THERAPY AND TESTS APPROXIMATELY 2-3 TIMES PER DAY (PER DATA IN METER'S MEMORY). THE PATIENT DENIED TAKING ANY ACTION REGARDING HIS USUAL DIABETES MANAGEMENT ROUTINE IN RESPONSE TO THE ALLEGED ISSUE. HE CLAIMED THAT ON (B)(6) 2013, HE DEVELOPED SYMPTOMS OF "NAUSEA AND LOSS OF VISION" AT AN UNKNOWN TIME. HE REPORTED GOING TO THE EMERGENCY ROOM (ER) ON (B)(6) 2013, AT APPROXIMATELY 7PM. HE ADVISED THAT HE WAS TREATED AT THE ER WITH IV FLUIDS AT 7PM ON THE DAY HE WAS ADMITTED. THE PATIENT REPORTED THAT HIS BLOOD GLUCOSE WAS TESTED USING AN ER DEVICE (UNKNOWN TYPE) AND REPORTED VALUES OF "150, 160, 198MG/DL" OVER A DATE RANGE OF (B)(6) 2013. IT IS NOT CLEAR IF THESE RESULTS WERE OBTAINED BEFORE OR AFTER THE TREATMENT, THIS WOULD HAVE BEEN HELPFUL TO KNOW. AT THE TIME OF TROUBLESHOOTING THE CCA CONFIRMED THE METER WAS SET TO THE CORRECT UNIT OF MEASURE, THE SUBJECT TEST STRIPS WERE IN GOOD CONDITION. A CONTROL SOLUTION TEST WAS NOT PERFORMED BECAUSE THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION AVAILABLE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS HE RECEIVED AN INACCURATE LOW RESULT ON THE SUBJECT DEVICE AND REPORTEDLY DEVELOPED SYMPTOMS AND RECEIVED TREATMENT THAT SUGGEST THAT THE PATIENT WAS HYPERGLYCEMIC AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104957 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3345372

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Life Threatening| R