BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 1806462 · Received August 18, 2010

    Report

    Report Number
    2939301-2010-06778
    Event Type
    Malfunction
    Date Received
    August 18, 2010
    Report Date
    July 28, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    MDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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. SPC TEST PORT FOUND DIRTY. 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

    A BIOMED TECHNICIAN (BT) CONTACTED A BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) REGARDING A TINA HEMODIALYSIS INSTRUMENT THAT HAD A LEAK WHICH OCCURRED DURING PROGRAMMING/SETUP. THE BT NEEDED INFORMATION ON HOW TO OPEN THE DOOR TO CHECK THE TUBING. THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. A FIELD SERVICE ENGINEER (FSE) RESPONDED TO THE CALL AND SPOKE WITH THE BT WHO STATED HE WANTED TO KNOW HOW TO OPEN THE HEMODIALYSIS MACHINE TO CHECK THE TUBING, DUE TO A LEAK IN THE MACHINE. (B)(4). THE BT INDICATED THAT HE WOULD DO THAT. THE FACILITY'S BT WAS CONTACTED ON (B)(4) 2010. THE BT INDICATED THAT THE INTERNAL TUBING OF THE TINA MACHINE CAME OFF OF THE CONNECTOR. THE BT JUST PUT THE TUBING BACK ONTO THE CONNECTOR AND WAS ABLE TO CONTINUE WITH THE SETUP WITHOUT ANY FURTHER PROBLEMS. NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THE METER DISPLAYS ERROR 5 MESSAGE. 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 MDS LIFESCAN, INC. 3004778

    Patients

    Seq Age Sex Outcome Treatment
    1