BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1832789 · Received September 13, 2010

    Report

    Report Number
    2939301-2010-07807
    Event Type
    Injury
    Date Received
    September 13, 2010
    Report Date
    September 8, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT'S PRODUCTS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER AND TEST STRIPS INVOLVED IN THIS CASE HAVE PASSED ALL TESTING WITH NO FAULTS FOUND. THE RETAIN TEST STRIPS ALSO PASSED ALL TESTING. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A SECOND FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    Additional Manufacturer Narrative · 1

    (DATE OF BIRTH) NOT PROVIDED. THE 510K # IS K053529.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) 2010, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THAT A BRAND NEW ONETOUCH ULTRA2 METER WAS PROMPTING AN "ERROR 5" MESSAGE. PER THE ONETOUCH ULTRA2 OWNER'S BOOKLET, THIS ERROR APPEARS WHEN THE METER HAS DETECTED A PROBLEM WITH THE TEST STRIP. POSSIBLE CAUSES ARE TEST STRIP DAMAGE OR AN INCOMPLETELY FILLED CONFIRMATION WINDOW. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DURING A FOLLOW-UP CALL. THE PATIENT REPORTED THAT THE ALLEGED ISSUE BEGAN TWO WEEKS PRIOR TO CONTACTING LFS; WHEN HE FIRST ATTEMPTED TO TEST WITH THE SUBJECT METER. THE PATIENT INFORMED THE CSR THAT HE TESTS 3X/DAY AND MANAGES HIS DIABETES WITH ORAL MEDICATIONS (METFORMIN AND DIAMICRON). THE PATIENT DENIED TAKING ANY ACTION REGARDING HIS USUAL DIABETES MANAGEMENT AS A RESULT OF THE ALLEGED ISSUE. A FEW HOURS AFTER THE ALLEGED ERROR MESSAGE APPEARED, THE PATIENT CLAIMED HE FELT SWEATY AND REPORTEDLY TREATED HIMSELF WITH CANDY AND JUICE. THE PATIENT STATED THE SYMPTOM LASTED APPROXIMATELY 30 MINUTES. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THAT THE TEST STRIP WAS NOT DRAWING THE SAMPLE INTO THE CONFIRMATION WINDOW. THE ISSUE REMAINED UNRESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS HE WAS UNABLE TO TEST HIS BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER THAT THE TIP OF A 60ML PREFILLED SYRINGE (CUSTOMER THINKS IT IS A BD SYRINGE, LOT 072620100254) THAT BROKE OFF INTO THE LUER OF AN ANTI-SIPHON PCA EXTENSION SET. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY. THE CONDITION OCCURRED WHILE CONNECTING THE TWO, BUT THE PATIENT WAS NOT ATTACHED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 3001839

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R