BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 4336011 · Received December 17, 2014

    Report

    Report Number
    2939301-2014-34617
    Event Type
    Injury
    Date Received
    December 17, 2014
    Report Date
    December 11, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    FOLLOWUP #1 - CORRECTION.THE INCIDENT DESCRIPTION HAS BEEN RE-WRITTEN TO INCLUDE DATA FROM 3 OTHER COMPLAINTS FROM WITH SAME METER, FROM THE SAME INCIDENT.

    Description of Event or Problem · 1

    ON (B)(6) 2014 LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) AND ALLEGED THEIR ONE TOUCH ULTRA 2 METER READ INACCURATELY HIGH COMPARED TO THEIR FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED AT THE END OF NOVEMBER THEY OBTAINED AN INACCURATE HIGH RESULTS OF ¿208, 183, 197, 187 MG/DL¿ WITH THE SUBJECT METER. THE PATIENT MANAGES HER DIABETES WITH INSULIN (SELF-ADJUSTER). THE PATIENT CONFIRMED THAT SHE DID MAKE ANY CHANGES TO HER USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED PRODUCT ISSUE; THE PATIENT ALLEGED AN INCREASE IN MEDICATION ON (B)(6) 2014 AT AN UNKNOWN TIME. THE PATIENT CLAIMS SHE DEVELOPED SYMPTOMS OF ¿QUEASY, LOW BLOOD SUGAR, SHAKING, NAUSEA, DIZZY¿ A WEEK OR TWO AFTER THE PRODUCT BEGAN. AT THE TIME OF TROUBLE SHOOTING, THE CCA CONFIRMED THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE. THE TEST STRIPS WERE NOT OPEN PAST THEIR DISCARD OR EXPIRY DATES AND THE TEST STRIPS WERE STORED CORRECTLY. THE CCA WAS UNABLE TO WALK THROUGH A RETEST AS PATIENT DID NOT HAVE CONTROL SOLUTION. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SEVERE LOW BLOOD GLUCOSE EXCURSION AFTER THE ALLEGED PRODUCT ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828307 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3596388

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR