BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 1902685 · Received November 18, 2010

    Report

    Report Number
    2939301-2010-10104
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Report Date
    November 4, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP # 1/SUPPLEMENTAL REPORT TEXT-11/19/2010. 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

    A HOME PATIENT (HP)'S NURSE CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT THAT A COMPACT EXCHANGE DEVICE (CXD) WAS NOT SPIKING THE BAGS CORRECTLY. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THAT THE UNIT MIGHT NEED TO BE CLEANED. THE TSR REVIEWED THE CLEANING PROCESS WITH THE NURSE PER THE CXD INSTRUCTION SHEET. THE NURSE UNDERSTOOD AND AGREED TO CLEAN THE UNIT. THE NURSE WOULD CALL BACK IF SHE WAS STILL HAVING ISSUES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. DURING A FOLLOW UP WITH THE NURSE REGARDING THE REPORTED EVENT, IT WAS REVEALED THAT THE HP'S SON HAD BROUGHT-IN THE CXD STATING THAT IT WAS NOT WORKING AT ALL. THE NURSE EXPLAINED THAT SHE COULD NOT SPECIFY THE PROBLEM BECAUSE SHE DID NOT SEE IT MALFUNCTION HERSELF. THE NURSE STATED SHE TRIED TO CLEAN IT AS DIRECTED BY TSR, BUT IT STILL DID NOT WORK. THE NURSE DID NOT TRY TO USE IT AGAIN ON ANY SUPPLIES. THE NURSE EXPLAINED THAT SHE WAS NOT AWARE OF ANY PRODUCT DAMAGE OR PATIENT INJURY AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE BLACK MARKS WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3020168

    Patients

    Seq Age Sex Outcome Treatment
    1