BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1762013 · Received July 19, 2010

    Report

    Report Number
    2939301-2010-05747
    Event Type
    Injury
    Date Received
    July 19, 2010
    Date of Event
    July 7, 2010
    Report Date
    July 7, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    LFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 LAY USER/PATIENT'S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE HAS PASSED TESTING WITH NO FAULTS FOUND. 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.

    Description of Event or Problem · 1

    THE LAY USER / PATIENT CONTACTED LFS ON (B) (6) 2010 ALLEGING AN APPLY SAMPLE MESSAGE ON HER ONE TOUCH ULTRA 2 METER. THE PATIENT MENTIONED THAT ON (B) (6) 2010 AT AROUND 5:00AM, SHE OBTAINED AN APPLY SAMPLE MESSAGE ON HER ONE TOUCH ULTRA 2 METER. AT 7:50AM, SHE DEVELOPED SYMPTOMS OF FEELING DIZZY AND SWEATY. SHE DID NOT SEEK ANY FURTHER MEDICAL ATTENTION OR CONTACT HER PHYSICIAN FOR ASSISTANCE. THIS WAS NOT THE FIRST TIME THE PRODUCT WAS BEING USED. WHILE TROUBLESHOOTING, IT WAS NOTED THAT THE TECHNIQUE OF APPLYING BLOOD WAS INCORRECT. THE PATIENT WAS APPLYING BLOOD TO THE SURFACE NOT THE TOP EDGE. THE ISSUE WAS NOT RESOLVED VIA TROUBLESHOOTING. THE METER WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT SINCE SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE, SHE DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING 20 FALSE HIGH CREATININE (CRE) RESULTS THAT WERE GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY; HOWEVER, THE SAMPLES WERE RERUN ON ANOTHER INSTRUMENT AND THE RESULTS WERE AMENDED. PATIENT #9 RESULTS WERE NOT PROVIDED BY THE CUSTOMER. IT IS UNKNOWN IF PATIENT TREATMENT WAS INITIATED OR WITHHELD WITH REGARD TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT LFR LIFESCAN, INC. 3003131

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening