BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 1870023 · Received October 15, 2010

    Report

    Report Number
    2939301-2010-09096
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Report Date
    October 12, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LAY USER/PATIENT'S PRODUCT(S) HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE FAILED TESTING. THE METER WAS FOUND TO HAVE CRACKED/BROKEN DISPLAY. 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

    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; 510 (K) # IS K082590.

    Description of Event or Problem · 1

    PATIENT IN INTENSIVE CARE UNIT (ICU) WAS ADMITTED FOR SEVERE HYPOTENSION. PATIENT WAS ORDERED TO RECEIVE LEVOPHED FOR THE HYPOTENSION. RN PRIMED AND HUNG THE LEVOPHED DRIP. PATIENT'S BLOOD PRESSURE DID NOT IMPROVE WITHIN THE FIRST 5- 10 MINUTES. RN INSPECTED THE IV LINE AND FOUND IT TO BE LEAKING AT THE FILTER SITE. THE RN REMOVED THE ULTRASITE TUBING AND OBTAINED A NEW SET FOR WHICH SHE REPRIMED AND STARTED DRIP AGAIN. PATIENT BEGAN TO HAVE INCREASE IN BLOOD PRESSURE AT THIS TIME. TUBING REMOVED AND SEQUESTERED FOR RISK MANAGEMENT. PATIENT REMAINS IN ICU. APPROXIMATELY 16 MINUTE DELAY IN SWITCHING OUT TUBING AND PATIENT RECEIVING ORDERED LEVOPHED.====================== HEALTH PROFESSIONAL'S IMPRESSION======================IT WAS LEAKING====================== MANUFACTURER RESPONSE FOR ULTRASITE IV TUBING, ULTRASITE======================ONGOING ISSUES WITH THIS TUBING.

    Description of Event or Problem · 1

    THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THE METER HAS BLACK MARKS ON THE DISPLAY. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WERE NO ALLEGATIONS OF HARM OR INJURY. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 3005342

    Patients

    Seq Age Sex Outcome Treatment
    1