BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 3230877 · Received July 17, 2013

    Report

    Report Number
    3008382007-2013-20036
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    July 5, 2013
    Report Date
    July 6, 2013
    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
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HIS ONETOUCH ULTRA2 METER READ INACCURATELY COMPARED TO HIS FEELINGS/ NORMAL BLOOD GLUCOSE RESULTS. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE PATIENT ON (B)(6) 2013 AND OBTAINED THE FOLLOWING INFORMATION. THE PATIENT TESTS HIS BLOOD GLUCOSE 3X DAILY AND HIS RESULTS ARE USUALLY AROUND ¿80-140 MG/DL.¿ THE PATIENT MANAGES HIS DIABETES WITH HUMALOG INSULIN (SLIDING SCALE) AND LANTUS INSULIN (65 UNITS). THE ALLEGED ISSUE BEGAN ON THE MORNING OF (B)(6) 2013. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS BETWEEN ¿80-90 MG/DL¿ (THAT MORNING) AND ¿BELOW 120 MG/DL¿ (LATER THAT SAME AFTERNOON AND EVENING). THE PATIENT REPORTEDLY CONTINUED TO ADMINISTER HIS USUAL DOSE OF HUMALOG INSULIN (10 UNITS) BASED ON THE REPORTED RESULTS. BY 9:25PM THAT SAME EVENING, THE PATIENT CLAIMED HE FELT LOW BLOOD GLUCOSE SYMPTOMS OF BLURRY VISION AND SWEATING. AT THE TIME OF HIS SYMPTOMS, THE PATIENT OBTAINED A BLOOD GLUCOSE RESULT OF ¿48 MG/DL¿ WITH THE SUBJECT METER. THE PATIENT TOOK JUICE AS TREATMENT AND FELT BETTER ABOUT 45 MINUTES LATER. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT. THE PATIENT DID NOT HAVE CONTROL SOLUTION TO PERFORM QUALITY CONTROL TESTING. THIS COMPLAINT IS BEING REPORTED BECAUSE, THE PATIENT CLAIMED HE OBTAINED INACCURATE HIGH READINGS ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULTS, AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330575 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3439830

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening| R