BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 4383194 · Received January 6, 2015

    Report

    Report Number
    2939301-2015-00247
    Event Type
    Injury
    Date Received
    January 6, 2015
    Report Date
    December 26, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT¿S METER HAS BEEN RETURNED ON (B)(6) 2015 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(6) 2015 WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED. 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 LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HER ONETOUCH ULTRA2 METER READ INACCURATELY HIGH COMPARED TO HER FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. IT IS NOT KNOWN WHEN THE ALLEGED METER INACCURACY BEGAN. THE PATIENT REPORTED OBTAINING READINGS OF ¿179, 170, 248, 171, 182, 226, 183, 167, 262, 212, 218 AND 233 MG/DL¿ WITH THE SUBJECT METER. THE PATIENT STATED THAT SHE MANAGES HER DIABETES WITH ORAL MEDICATION, DIET AND EXERCISE AND CLAIMED SHE TOOK LESS FOOD IN RESPONSE TO THE ALLEGED INACCURATE READINGS. THE PATIENT REPORTED DEVELOPING SYMPTOMS OF ¿NAUSEA, SHAKINESS, CONFUSION AND THIRST¿ 2-3 HOURS AFTER THE INACCURACY ISSUE BEGAN. THE PATIENT DENIED RECEIVING MEDICAL TREATMENT. DURING TROUBLESHOOTING, THE CSR CONFIRMED THAT THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER. THE CSR WALKED THE PATIENT THROUGH A CONTROL SOLUTION TEST AND THE RESULT FELL WITHIN THE SPECIFIED CONTROL SOLUTION RANGE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED PRODUCT ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7788 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3683841

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Life Threatening