BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 2220801 · Received August 23, 2011

    Report

    Report Number
    2939301-2011-07919
    Event Type
    Injury
    Date Received
    August 23, 2011
    Report Date
    August 12, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ((B)(4) 2011)-DEVICE EVALUATION: THE METER AND TEST STRIPS INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4), 2011 WITH THE FOLLOWING FINDINGS: THE METER AND TEST STRIPS HAVE PASSED ALL TESTING WITH NO FAULTS FOUND. THE RETAIN TEST STRIPS ALSO PASSED ALL TESTING. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    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. THE 510(K) # IS K073231.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY-USER/PATIENT'S DAUGHTER-IN-LAW CONTACTED LIFESCAN (LFS) TO REPORT EXPERIENCING AN INACCURATE ERRATIC ISSUE AND AN INACCURATE HIGH ISSUE WITH HER MOTHER-IN-LAW'S ONE TOUCH ULTRALINK METER. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE PATIENT ON (B)(4) 2011 AND OBTAINED THE FOLLOWING INFORMATION. THE PATIENT'S DAUGHTER-IN-LAW REPORTED THAT THE FIRST ISSUE OF THE ALLEGED INACCURATE HIGH ISSUE BEGAN APPROXIMATELY 2 MONTHS PRIOR TO CONTACTING LFS. SHE STATED THAT THE PATIENT OBTAINED A RESULT OF "202 MG/DL" ON THE SUBJECT METER AND A "LOW READING" ON ANOTHER METER (COULD NOT RECALL THE RESULT), DONE WITHIN 30 MINUTES OF EACH OTHER. THE SECOND ISSUE OF THE ALLEGED INACCURATE ERRATIC ISSUE WITH THE SUBJECT METER BEGAN APPROXIMATELY 2 WEEKS PRIOR TO CONTACTING LFS. SHE REPORTED THAT THE PATIENT OBTAINED RESULTS OF "202 MG/DL AND 112 MG/DL" ON THE SUBJECT METER, PERFORMED LESS THAN 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 REPORTER INFORMED THIS MSS, THAT THE PATIENT TESTS HER GLUCOSE EVERY 2 HOURS AND MANAGES HER DIABETES WITH INSULIN (PUMP THERAPY). IN RESPONSE TO THE HIGH RESULTS, ON BOTH INSTANCES THE PATIENT WAS IMMEDIATELY TREATED BY THE PUMP WITH INSULIN, BASED ON THE VALUES OBTAINED. THE DAUGHTER-IN-LAW CLAIMED THAT IN BOTH CASES, APPROXIMATELY 15 MINUTES AFTER THE INSULIN TREATMENT, THE PATIENT FELT SWEATY, WAS HOT AND PASSED OUT. PER THE DOCUMENTATION, DURING THE MOST RECENT INCIDENT, THE PATIENT'S GLUCOSE WAS TESTED WITH ANOTHER DEVICE, AND A RESULT OF "25 MG/DL" WAS OBTAINED (COULD NOT RECALL TIME TESTED). THE REPORTED STATED THAT IN BOTH INSTANCES SINCE SHE WAS ALREADY UNCONSCIOUS, THEY HAD TO TREAT AND REVIVE THE PATIENT WITH A GLUCAGON INJECTION. DURING THE INITIAL CALL WITH CUSTOMER SERVICE, THE AGENT NOTED THAT THE PATIENT WAS USING THE CORRECT UNIT OF MEASURE SET IN THE METER, CORRECT UNEXPIRED STRIPS AND WAS USING AN APPROPRIATE SAMPLE SITE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT'S REPORTER CLAIMS THAT IN 2 DIFFERENT INSTANCES, THE PATIENT OBTAINED INACCURATE HIGH READINGS ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED HIGH 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. 3149926

    Patients

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