BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 2884353 · Received December 22, 2012

    Report

    Report Number
    3008382007-2012-08922
    Event Type
    Injury
    Date Received
    December 22, 2012
    Report Date
    December 15, 2012
    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
    WA, 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 (02/06/2013)-DEVICE EVALUATION: THE PRODUCTS INVOLVED WITH THIS COMPLAINT HAVE BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS (PA) RESPECTIVELY ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE METER WAS EVALUATED AND THE PRIMARY COMPLAINT WAS NOT CONFIRMED; HOWEVER, A SECONDARY ISSUE WAS NOTED WHERE THE METER WAS FOUND TO HAVE A DEFECTIVE U5 PROCESSOR CAUSING THE METER TO TURN ON INTERMITTENTLY. THE TEST STRIPS ALSO 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) 2012, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRALINK METER READ INACCURATELY HIGH. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE REPORTER ON (B)(6) 2012 AND OBTAINED THE FOLLOWING INFORMATION. IT IS NOT CLEAR WHEN THE ALLEGED ISSUE BEGAN. ON THE EVENING OF (B)(6) 2012, THE REPORTER CLAIMS THE PATIENT WENT TO BED "OKAY;" HOWEVER, DID NOT PROVIDE SPECIFIC BLOOD GLUCOSE RESULTS THAT EVENING. THE PATIENT'S USUAL BLOOD GLUCOSE RESULT IS AROUND "125 MG/DL." THE PATIENT MANAGES HER DIABETES WITH INSULIN. DURING THE INITIAL CALL, IT WAS REPORTED THE PATIENT ADMINISTERED SELF AN INCREASED DOSE OF NOVOLOG INSULIN (AMOUNT NOT SPECIFIED) THAT SAME EVENING. ON THE FOLLOWING EARLY MORNING, THE REPORTER CLAIMS THE PATIENT HAD TROUBLE "WAKING UP" AND WAS NOT RESPONSIVE. THE REPORTER TESTED THE PATIENT'S BLOOD GLUCOSE AT "36 MG/DL" WITH THE SUBJECT METER. THE REPORTER ADMINISTERED THE PATIENT A GLUCAGON INJECTION AS TREATMENT. THE PATIENT REPORTEDLY STARTED TALKING BUT WAS "SLURRING HER WORDS." AT THAT TIME, THE PATIENT'S BLOOD GLUCOSE WAS "60 MG/DL." THE REPORTER TOOK THE PATIENT TO THE EMERGENCY ROOM (ER) WHERE A COMPARISON WAS MADE BETWEEN THE SUBJECT METER AND THE HOSPITAL METER. IT WAS REPORTED THE PATIENT OBTAINED A BLOOD GLUCOSE RESULTS OF "200 MG/DL" WITH THE SUBJECT METER AND "172 MG/DL" ON THE HOSPITAL METER, PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS DO NOT EXCEED THE EXPECTED VALUE OF <= 30% AND/OR <= 30 MG/DL. PER THE REPORTER, ADDITIONAL TREATMENT WAS NOT PROVIDED WHILE AT THE ER. THE PATIENT WAS KEPT IN THE HOSPITAL FOR 16 HOURS FOR OBSERVATIONS BEFORE BEING SENT HOME. 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. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT MAY HAVE OBTAINED AN INACCURATE HIGH READING ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULT, AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3355295

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| L| R