BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2068731 · Received April 25, 2011

    Report

    Report Number
    2939301-2011-03365
    Event Type
    Injury
    Date Received
    April 25, 2011
    Report Date
    April 11, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) SPOKE TO THE PATIENT ON (B)(6) 2011 TO OBTAIN THE FOLLOWING INFORMATION. THE PATIENT CONFIRMED THE ALLEGED ISSUE BEGAN APPROXIMATELY A MONTH AGO. IN ADDITION IN INSULIN, THE PATIENT MANAGES HER DIABETES WITH METFORMIN (500MG) PILLS. THE PATIENT STATED HER NORMAL BLOOD GLUCOSE READING ARE BETWEEN "112-120 MG/DL". THE PATIENT CONFIRMED SHE DID NOT DEVELOPED ANY DIABETIC SYMPTOMS. THIS COMPLAINT IS BEING RULED-OUT AS REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION(S): THE PATIENT DID NOT DEVELOP SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA OR HYPERGLYCEMIA, NOR DID SHE RECEIVE MEDICAL INTERVENTION FOR EITHER OF THESE CONDITIONS. DESELECTED ADVERSE EVENT. DESELECTED LIFE THREATENING. DESELECTED SERIOUS INJURY.

    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. 510(K) # IS K062195.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 2 (06/22/2011)-DEVICE EVALUATION: THE METER AND TEST STRIPS INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: ON (B)(6), 2011 THE METER HAS PASSED ALL TESTING WITH NO FAULTS FOUND. ON (B)(6), 2011 THE 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.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA METER WAS READING INACCURATELY HIGH. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT FOR FOLLOW-UP QUESTIONS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT WAS NOT ABLE TO SPECIFY WHEN THE ALLEGED ISSUE BEGAN. THE PATIENT REPORTED OBTAINING ALLEGED HIGH READING OF "232, 223, AND 226 MG/DL" WITH THE SUBJECT METER. THE PATIENT INDICATED SHE MANAGES HER DIABETES WITH INSULIN. DESPITE THE ALLEGED ISSUE, THE PATIENT CLAIMED SHE CONTINUED TO ADMINISTER HER USUAL HUMULIN 70/30 DOSE OF INSULIN EVERY DAY AT 7:00AM AND 6:00PM OR 9:00PM. AT AN UNKNOWN DATE/TIME, THE PATIENT REPORTED FEELING SWEATY AFTER THE ALLEGED ISSUE BEGAN. IN SPITE OF HER SYMPTOM, THE PATIENT DENIED SEEKING ANY MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER'S UNIT OF MEASURE WAS SET CORRECTLY; HOWEVER THE PATIENT WAS UNABLE/UNWILLING TO PERFORM A QUALITY CONTROL SOLUTION 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 ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Life Threatening