BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 3010792 · Received March 19, 2013

    Report

    Report Number
    3008382007-2013-05570
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Report Date
    February 19, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K073231
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE METER HAS PASSED TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED. 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 HER ONETOUCH ULTRALINK METER WAS READING INACCURATELY HIGH COMPARED TO HER FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY THE MEDICAL SURVEILLANCE SPECIALIST (MSS) DURING A FOLLOW-UP CALL WITH THE PATIENT ON (B)(6) 2013. THE PATIENT INFORMED THE MSS THAT ON (B)(6) 2013 AT APPROXIMATELY 10:00AM, HER FIANCÉE FOUND HER "UNRESPONSIVE" WHEN ATTEMPTING TO WAKE HER UP. THE PATIENT DENIED EXPERIENCING ANY OTHER SYMPTOMS. THE PATIENT STATED THAT HER FIANCÉE TESTED HER BLOOD GLUCOSE WITH THE SUBJECT METER AND OBTAINED A READING OF "71 MG/DL" AND THEN IMMEDIATELY CONTACTED EMERGENCY SERVICES. WHEN EMERGENCY SERVICES ARRIVED, THE PATIENT CLAIMED HER BLOOD GLUCOSE WAS RETESTED WITH THE EMS METER AND THEY OBTAINED A RESULT OF "31 MG/DL." THE PATIENT CONFIRMED BOTH TESTS WERE PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF LESS THAN OR EQUAL TO 30% AND/OR 30 MG/DL. THE PATIENT REPORTED SHE WAS TREATED FOR THE LOW BLOOD GLUCOSE EXCURSION AND TAKEN TO THE EMERGENCY ROOM. THE PATIENT INFORMED THE MSS THAT SHE IS ON INSULIN PUMP THERAPY. PRIOR TO OBTAINING THE ALLEGED INACCURATE HIGH READING ON THE MORNING OF (B)(6) 2013, THE PATIENT STATED SHE HAD LAST TESTED HER BLOOD GLUCOSE THE EVENING PRIOR, BUT DID NOT RECALL WHAT THE READING WAS. THE PATIENT DID NOT KNOW WHAT MAY HAVE CAUSED AND/OR CONTRIBUTED TO THE SEVERE LOW BLOOD GLUCOSE EXCURSION. AT THE TIME OF TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE NOTED THAT PATIENT DID NOT HAVE CONTROL SOLUTION AVAILABLE TO TEST THE SUBJECT METER. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. ALTHOUGH THE PATIENT WAS TREATED FOR SEVERE HYPOGLYCEMIA BY AN HCP, THERE IS NO INDICATION THAT THE ALLEGED METER ISSUE CAUSED OR CONTRIBUTED TO THIS SERIOUS INJURY. THE PATIENT WAS SYMPTOMATIC PRIOR TO HAVING OBTAINED THE ALLEGED INACCURATE HIGH READING. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE SUBJECT METER DID NOT MEET LFS' ACCURACY CRITERIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114159 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3377628

    Patients

    Seq Age Sex Outcome Treatment
    1