BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 1822000 · Received September 1, 2010

    Report

    Report Number
    2939301-2010-07467
    Event Type
    Malfunction
    Date Received
    September 1, 2010
    Report Date
    August 28, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    MDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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

    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.

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

    GENERAL REPORT RECEIVED OF AN UNSPECIFIED NUMBER OF UNDOCUMENTED INCIDENTS OF NO FLOW. THE PRIMARY TUBING SETS WERE BEING USED TO DELIVER UNSPECIFIED SOLUTIONS VIA BAXTER 6200 INFUSION PUMPS. AFTER UNSPECIFIED LENGTHS OF TIME IN USE, THE SECONDARY TUBING SETS WERE CONNECTED TO THE PRIMARY TUBING SETS FOR PIGGYBACK DELIVERIES OF UNSPECIFIED SOLUTIONS. THE SECONDARY SOLUTION CONTAINERS WERE HUNG HIGHER THAN THE PRIMARY SOLUTION CONTAINERS. AFTER UNSPECIFIED LENGTHS OF TIME IN USE, THE NURSES RETURNED TO THE PATIENT'S ROOM AND NOTED THAT THE SECONDARY SOLUTION CONTAINERS WERE FULL. THE NURSES EXPECTED THE SOLUTION CONTAINERS TO BE EMPTY. IT WAS REPORTED THAT EITHER THE SECONDARY TUBING SETS WERE REPLACED OR THE SECONDARY SOLUTIONS WERE DELIVERED WITHOUT AN INFUSION PUMP. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAYS IN THERAPIES FOR THESE PATIENTS. NO MEDICAL INTERVENTIONS WERE REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1