BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 4335355 · Received December 17, 2014

    Report

    Report Number
    2939301-2014-34536
    Event Type
    Injury
    Date Received
    December 17, 2014
    Report Date
    December 8, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K062195
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (01/26/2015). THE PATIENT¿S METER AND TEST STRIPS HAVE BEEN RETURNED ON 1/9/2015 AND 1/16/2015, RESPECTIVELY, AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 1/13/2015 AND 1/16/2015, RESPECTIVELY, WITH THE FOLLOWING FINDINGS:THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED; HOWEVER, A SECONDARY ISSUE WAS NOTED WHEN THE METER WAS FOUND TO HAVE A SMEARED PRINT LABEL. THE TEST STRIPS WERE ALSO TESTED AND THE PRIMARY COMPLAINT WAS NOT CONFIRMED. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2014 THE REPORTER CONTACTED LIFESCAN (LFS) ALLEGING THAT THE PATIENT¿S ONETOUCH ULTRA METER WAS READING INACCURATELY HIGH COMPARED TO THEIR FEELINGS AND/OR NORMAL READINGS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE REPORTER ALLEGED THAT THE PRODUCT ISSUE BEGAN IN THE MIDDLE OF NOVEMBER. THE REPORTER STATED THAT THE PATIENT OBTAINED BLOOD GLUCOSE READINGS OF ¿191, 178, 161, 159, 163, 157, 153, 163, 188, 148 AND 170MG/DL¿. THE PATIENT MANAGES THEIR DIABETES WITH PILLS, DIET AND EXERCISE. THE REPORTER STATED THAT THE PATIENT DID NOT MAKE ANY CHANGES TO THEIR USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED INACCURATE READINGS. THE PATIENT REPORTEDLY DEVELOPED A SYMPTOM OF ¿SHAKINESS¿ SOMETIME AFTER THE PRODUCT ISSUE BEGAN. THE REPORTER STATED THAT THE PATIENT DID NOT RECEIVE ANY TREATMENT FOR THIS SYMPTOM. AT THE TIME OF TROUBLESHOOTING THE CSR VERIFIED THAT THE TEST STRIPS WERE STORED CORRECTLY (PER OWNER¿S BOOKLET RECOMMENDATION). THE REPORTER DID NOT HAVE CONTROL SOLUTION AVAILABLE TO TEST THE SUBJECT METER. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT DEVELOPED SYMPTOM SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED INACCURACY BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828709 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3649932

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Life Threatening