BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 2011061 · Received March 8, 2011

    Report

    Report Number
    2939301-2011-01990
    Event Type
    Malfunction
    Date Received
    March 8, 2011
    Date of Event
    February 21, 2010
    Report Date
    February 21, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510 (K) # IS K073231. DEVICE EVALUATION: THE METER INVOLVED IN THIS COMPLAINT WAS RETURNED AND THE METER PASSED TESTING. THE 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. 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

    (B)(4). THE TEST STRIPS INVOLVED WITH THIS COMPLAINT HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: THE TEST STRIPS HAVE 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

    THE LAY REPORTER CONTACTED LFS ON (B)(6) 2011 ALLEGING INACCURATE ERRATIC READINGS ON THE PATIENT'S ONE TOUCH ULTRALINK METER. THE PATIENT OBTAINED RESULTS BELOW 20 MG/DL AND 174 MG/DL ON THE METER LESS THAN 20 MINUTES FROM ONE ANOTHER. THE PATIENT DID NOT EXHIBIT ANY SYMPTOMS DUE TO THE ALLEGED ISSUE. DUE TO THE ALLEGED READINGS THE PATIENT'S MOTHER TREATED THE PATIENT WITH A JUICE BOX AND & 1.3 - 1.4 UNITS OF INSULIN TO COVER FOR THE JUICE AND BECAUSE OF THE RESULT OF 174MG/DL. THE PATIENT DID NOT SEEK ANY FURTHER MEDICAL ATTENTION OR CONTACT THEIR PHYSICIAN FOR ASSISTANCE. THE TEST STRIP VIAL WAS NOT CRACKED OR BROKEN. THE TEST STRIP WAS NOT EXPIRED. A QUALITY CONTROL TEST WAS NOT DONE SINCE THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION. THE PRODUCT WAS REPLACED. AT THIS TIME THERE IS NO EVIDENCE THAT THE METER CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT, SINCE THE PATIENT DENIED EXHIBITING ANY SYMPTOMS. THE PATIENT'S TREATMENT CORRELATED WITH HER BLOOD GLUCOSE READING. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT OBTAINED A RESULT BELOW 20 MG/DL AND DID NOT EXHIBIT ANY SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 2955366

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR