BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 2060376 · Received April 15, 2011

    Report

    Report Number
    2939301-2011-03140
    Event Type
    Injury
    Date Received
    April 15, 2011
    Report Date
    April 6, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (05/11/2011)-DEVICE EVALUATION: THE LAY USER/PATIENT'S PRODUCT(S) 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 MOTHER CONTACTED LIFESCAN (LFS) ALLEGING THAT THE PATIENT'S ONETOUCH ULTRALINK METER WAS READING INACCURATELY. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE TO THE LAY USER/PATIENT'S MOTHER FOR FOLLOW-UP QUESTIONS ON (B)(6) 2011 AND OBTAINED/VERIFIED THE FOLLOWING INFORMATION. THE PATIENT'S MOTHER REPORTED THE ALLEGED ISSUE BEGAN APPROXIMATELY A MONTH AGO PRIOR TO CONTACTING LFS. THE PATIENT'S MOTHER REPORTED BLOOD GLUCOSE READINGS OF "379, 71, 455, AND 355 MG/DL" WITH THE SUBJECT METER OBTAINED ON SEVERAL OCCASION. THE MOTHER STATED THE PATIENT IS ON AN INSULIN PUMP TO MANAGE HER DIABETES. THE MOTHER WAS NOT ABLE TO CONFIRM WHAT ACTION THE PATIENT TOOK AS A RESULT OF THE ALLEGED ISSUE. ACCORDING TO THE MOTHER, THE PATIENT HAD GONE INTO A SEIZURE AFTER THE ALLEGED ISSUE BEGAN. IN RESPONSE TO THE SYMPTOM, THE MOM STATED SHE TREATED THE PATIENT, BUT SHE COULD NOT RECALL WHETHER SHE GAVE THE PATIENT GLUCOSE TABLETS OR HAD HER DRANK JUICE THAT DAY. AN HOUR AFTER TREATMENT WAS ADMINISTERED TO THE PATIENT, THE MOTHER CONFIRMED THE PATIENT FELT BETTER AND WAS ABLE TO BRING THE PATIENT TO SCHOOL. THE MOTHER CONFIRMED NO OTHER BLOOD GLUCOSE DEVICE WAS USED AT THE TIME OF THE ALLEGED ISSUE. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE PATIENT'S PROCESS FOR TESTING WAS CORRECT, THE RESULTS OBTAINED WERE FROM THE SAME APPROVED SAMPLE SITE, AND THE SUBJECT METER'S UNIT OF MEASURE WAS SET CORRECTLY. THE PATIENT'S MOTHER DID NOT HAVE THE CONTROL SOLUTION TO PERFORM A QUALITY CONTROL TEST. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY 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. 3040569

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Life Threatening| R