BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 3230756 · Received July 17, 2013

    Report

    Report Number
    3008382007-2013-19953
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Report Date
    July 4, 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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    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 (08/12/2013)-DEVICE EVALUATION: THE ANALYSIS OF THE SUBJECT METER WAS COMPLETED ON 08/06/2013 BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE REPORTED COMPLAINT COULD NOT BE REPRODUCED DURING INVESTIGATION. THE METER FUNCTIONED NORMALLY AND NO ISSUES WERE 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 HIS ONETOUCH ULTRALINK METER READ INACCURATELY HIGH COMPARED TO ANOTHER DEVICE. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE PATIENT ON (B)(6) 2013 AND OBTAINED THE FOLLOWING INFORMATION. THE PATIENT TESTS HIS BLOOD GLUCOSE 6X DAILY AND MANAGES HIS DIABETES WITH INSULIN (TYPE/ AMOUNT NOT SPECIFIED). THE ALLEGED ISSUE BEGAN ON (B)(6) 2013 AT 1155AM. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF ¿85 MG/DL¿ WITH THE SUBJECT METER AND ¿40 MG/DL¿ ON ANOTHER METER, PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 30% AND/OR <= 30 MG/DL. PRIOR TO TESTING, THE PATIENT CLAIMED HE HAD SYMPTOMS OF DILATED PUPILS, MUSCLE SPASMS, SLURRED SPEECH, NOT THINKING STRAIGHT, HANDS SHAKY AND NUMBNESS AROUND HIS MOUTH. PER THE ADVICE OF HIS WIFE, THE PATIENT ADMINISTERED SELF GLUCOSE GEL AS TREATMENT. PRIOR TO HIS REPORTED SYMPTOMS, THE PATIENT OBTAINED A BLOOD GLUCOSE RESULT OF ¿127 MG/DL¿ EARLIER THAT SAME MORNING WITH THE SUBJECT METER. THE PATIENT DENIED MAKING CHANGES TO HIS USUAL MANAGEMENT ROUTINE. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT AND AN APPROVED SAMPLE SITE WAS USED FOR TESTING. THE PATIENT DID NOT HAVE CONTROL SOLUTION TO PERFORM QUALITY CONTROL TESTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT¿S SYMPTOMS STARTED BEFORE THE REPORTED ISSUE FIRST OCCURRED AND THERE IS NO EVIDENCE THE PATIENT ADMINISTERED INAPPROPRIATE SELF TREATMENT DUE TO THE ALLEGED ISSUE. 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
    332334 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3257150

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR