BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2853912 · Received December 3, 2012

    Report

    Report Number
    3008382007-2012-07019
    Event Type
    Injury
    Date Received
    December 3, 2012
    Report Date
    November 5, 2012
    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
    MI, 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

    (B)(4): THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE ERROR COULD NOT BE REPRODUCED. THE TEST STRIPS WERE ALSO TESTED AND THE PRIMARY COMPLAINT WAS NOT CONFIRMED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.DEVICE RETURNED TO MFG DATE:TEST STRIPS- 12/12/2012,METER- 12/13/2012.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA2 METER WAS READING INACCURATELY HIGH COMPARED TO ANOTHER DEVICE. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT ALLEGED THAT THE ISSUE BEGAN ON (B)(6) 2012 AT 12:30AM. ON AN UNSPECIFIED DATE/TIME, THE PATIENT REPORTEDLY OBTAINED A BLOOD GLUCOSE READING OF "210 MG/DL" WITH THE SUBJECT METER AND "189 MG/DL WITH ANOTHER METER WHILE AT HER DOCTOR'S OFFICE. THE PATIENT MANAGES HER DIABETES WITH INSULIN (BASED ON HER BLOOD GLUCOSE READING). THE PATIENT DENIED MAKING ANY CHANGES TO HER DIABETES REGIMEN AFTER THE ALLEGED ISSUE OCCURRED. AS A RESULT OF THE ALLEGED METER ISSUE, THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS OF SHAKING, DIZZINESS, AND SWEATING (DATE/TIME UNKNOWN). ACCORDING TO THE CSR'S DOCUMENTATION, AT THE SAME TIME THE ALLEGED ISSUE OCCURRED (AND ON MULTIPLE OCCASIONS; DATE/TIME NOT SPECIFIED), THE PATIENT REPORTEDLY WAS ADMINISTERED A GLUCAGON INJECTION BY AN NON HEALTH CARE PROFESSIONAL AS TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CSR VERIFIED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT. HOWEVER, THE CSR NOTED THAT AT THE TIME OF THE ALLEGED ISSUE, THE PATIENT HAD USED VENOUS BLOOD; AN UNAPPROVED SAMPLE SITE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: ALTHOUGH THE PATIENT HAD USED BLOOD SAMPLE FROM AN UNAPPROVED SAMPLE SITE, THE PATIENT CLAIMS SHE DEVELOPED SYMPTOMS OF A SERIOUS INJURY AND WAS REPORTEDLY TREATED FOR SEVERE HYPOGLYCEMIA BY A NON-HCP WHILE USING THE LFS PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3348137

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Life Threatening| R