BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 4339322 · Received December 18, 2014

    Report

    Report Number
    2939301-2014-34789
    Event Type
    Injury
    Date Received
    December 18, 2014
    Report Date
    December 10, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (01/17/2015), THE PATIENT¿S METER HAS BEEN RETURNED ON (B)(4) 2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 1/7/2015 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 LOW BATTERY. 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 PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA 2 METER READ INACCURATELY ERRATIC AS WELL AS INACCURATELY HIGH COMPARED TO NORMAL RESULTS/FEELINGS AND THE WAS METER DISPLAYING BATTERY INDICATOR MESSAGE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE CCA WAS ADVISED BY THE PATIENT THAT THE ALLEGED INACCURACY BEGAN ON ¿1 MONTH AGO, UNKNOWN DATE AND TIME¿. THE PATIENT REPORTED OBTAINING INACCURATE ERRATIC BLOOD GLUCOSE RESULTS OF ¿212, 277, 212, 187, 215, AND 313 MG/DL¿ ON THE SUBJECT METER, TESTED WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS LIFESCAN¿S CRITERIA FOR ACCURACY. IT WAS ALSO AT THIS TIME THE PATIENT REPORTED INACCURATE HIGH COMPARED WITH NORMAL RESULTS/FEELINGS AND BATTERY INDICATOR MESSAGE. THE PATIENT REPORTED THAT SHE CURRENTLY TAKES INSULIN (SELF-ADJUSTER) TO MANAGE HER DIABETES AND¿1 MONTH AGO, UNKNOWN DATE AND TIME¿ INCREASED HER DOSE OF MEDICATIONS TO 16 UNITS AS PART OF HER USUAL DIABETES MANAGEMENT REGIMEN DUE TO THE ALLEGED ISSUES. ON ¿(B)(6) 2014, 2:46PM¿ THE PATIENT REPORTED TO DEVELOP THE SYMPTOMS OF ¿ACHEY ALL OVER AND HAD THE SHAKES¿ THE PATIENT DENIED RECEIVING ANY TREATMENT FOR THIS CONDITION. AT THE TIME OF TROUBLESHOOTING, THE CCA DETERMINED THAT THE CORRECT SAMPLE SITE AND TEST STRIPS WERE USED AT THE TIME OF TESTING AND THAT THE BATTERY REQUIRED REPLACING. CCA ALSO NOTED THAT THE PATIENT HAD NO CONTROL SOLUTION. REPLACEMENT PRODUCTS HAVE BEEN SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED; THIS COMPLAINT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSIONS: THE PATIENT DID SUFFER SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED PRODUCT ISSUE BEGAN. ADDITIONALLY THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE REMAINED UNRESOLVED AT THE TIME OF TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830983 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR