BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 3946213 · Received July 21, 2014

    Report

    Report Number
    2939301-2014-18028
    Event Type
    Injury
    Date Received
    July 21, 2014
    Date of Event
    July 11, 2014
    Report Date
    July 11, 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
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 2 ¿ (09/23/2014). THE LAY USER/PATIENT¿S METER HAVE BEEN RETURNED ON 08/19/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 09/20/2014 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

    FOLLOW-UP # 1 ¿ (09/04/2014). THE LAY USER/PATIENT¿S PRODUCTS HAVE BEEN RETURNED, AND WERE EVALUATED ON 08/29/2014 BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS:THE TEST STRIPS PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE CONFIRMED. 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) (B)(4) ALLEGING HIS ONE TOUCH ULTRA 2 METER READ INACCURATELY HIGH COMPARED HIS FEELINGS AND OR NORMAL RESULTS. THIS COMPLAINT IS BEING CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE¿S (CSR) DOCUMENTATION, SINCE THE PATIENT COULD NOT BE REACHED BY PHONE TO OBTAIN ADDITIONAL INFORMATION. THE PATIENT REPORTED THAT THE ALLEGED INACCURACY BEGAN ON (B)(6) 2014 AT 9:30 A. M. WHEN HE OBTAINED A BLOOD GLUCOSE READING OF ¿10.8 MMOL/L¿ WITH THE SUBJECT METER. AT 11:20 A. M. THE PATIENT RETESTED HIS BLOOD GLUCOSE AND OBTAINED A READING OF ¿7.4 MMOL/L¿ WITH THE SUBJECT METER. THE PATIENT MANAGES HIS DIABETES WITH INSULIN (UNKNOWN TYPE, SELF- ADJUSTER). IT IS NOT KNOWN IF THE PATIENT MADE ANY CHANGES TO HIS USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED INACCURATE READING(S) OBTAINED WITH THE SUBJECT METER. ON (B)(6) 2014 AT 11:35 A.M. THE PATIENT STATED THAT HE DEVELOPED SYMPTOMS OF ¿HUNGER, FEELING SHAKY AND LOW BLOOD SUGAR AFFECTING HIS HEAD¿. IMMEDIATELY AFTER, THE PATIENT SELF-TREATED WITH FOOD AND/OR DRINK. DURING TROUBLESHOOTING, THE CSR CONFIRMED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE SETTING. THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION AT THE TIME TO TEST THE SUBJECT METER AND TEST STRIPS. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SIGNS/SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424840 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3548148

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Life Threatening| R