BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 2183163 · Received July 28, 2011

    Report

    Report Number
    2939301-2011-06579
    Event Type
    Injury
    Date Received
    July 28, 2011
    Report Date
    July 5, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER AND TEST STRIPS INVOLVED WITH THIS COMPLAINT HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(6) 2011WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE TEST STRIPS WERE ALSO TESTED AND THE PRIMARY COMPLAINT WAS NOT CONFIRMED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED. 510(K) # IS K073231.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRALINK METER WAS READING INACCURATELY ERRATIC. 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 ALLEGED ISSUE BEGAN ON (B)(6) 2011 BETWEEN 7:00-7:30 PM. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "79 MG/DL, 214MG/DL, AND 192MG/DL" WITH THE SUBJECT METER, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <=20% AND/ OR <=20 MG/DL. THE PATIENT INFORMED THE CCA THAT SHE MANAGES HER DIABETES WITH HUMALOG INSULIN USING AN INSULIN PUMP. IT WOULD HAVE BEEN HELPFUL TO UNDERSTAND WHAT PROMPTED THE PATIENT TO REPEAT THE TEST AFTER PERFORMING THE INITIAL BLOOD TEST ON THE SUBJECT METER AND WHETHER THERE WAS ANY FORM OF INTERVENTION IN BETWEEN THE TESTS. THE PATIENT CLAIMED THAT SHE ADMINISTERED "1.2 UNITS" OF HUMALOG INSULIN BETWEEN 7:30 AND 8PM ON THAT SAME NIGHT AND REPORTEDLY BEGAN TO FEEL "LIGHT HEADED AND SHAKY" IMMEDIATELY AFTERWARDS. AT AROUND THAT SAME TIMEFRAME, THE PATIENT REPORTEDLY CHECKED HER BLOOD GLUCOSE ON ANOTHER METER CALLED "TRUE TEST" AND RECEIVED A READING OF "62 MG/DL." AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT PATIENT'S TESTING TECHNIQUE WAS CORRECT; THE TEST STRIPS APPEARED TO BE IN GOOD CONDITION AND THE SAMPLE WAS DRAWN FROM AN APPROVED SITE. THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION TO CHECK THE SUBJECT METER AND TEST STRIPS. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE OBTAINED INACCURATE ERRATIC READINGS ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULTS, AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3077066

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Life Threatening