BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 1940005 · Received December 28, 2010

    Report

    Report Number
    2939301-2010-11112
    Event Type
    Malfunction
    Date Received
    December 28, 2010
    Report Date
    December 5, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    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.(B)(4).

    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 CRACKED DISPLAY WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Description of Event or Problem · 1

    THIS IS A SOLICITED REPORT BY A NURSE FROM (B)(6) OF STERILE PERITONITIS IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON (B)(6) 2010, THE PATIENT EXPERIENCED STERILE PERITONITIS, MANIFESTED BY CLOUDY EFFLUENT. THE PATIENT DID NOT REQUIRE HOSPITALIZATION. ON (B)(6) 2010, THE PATIENT BEGAN REMEDIAL THERAPY WITH VANCOMYCIN (2G, LOADING DOSE, IP), GENTAMYCIN (40MG, LOADING DOSE, IP) AND CIPROFLOXACIN (250MG, DAILY, ORAL) WHICH WAS DISCONTINUED ON (B)(6) 2010. ON THAT SAME DATE, THE PATIENT HAD RECOVERED FROM THE EVENT OF STERILE PERITONITIS. DIANEAL UNKNOWN BAG, EXTRANEAL VIAFLEX AND NUTRINEAL PD4 UNKNOWN BAG THERAPIES WERE REPORTED AS ONGOING. THE REPORTER DID NOT PROVIDE A STATEMENT OF CAUSALITY FOR THE EVENT OF STERILE PERITONITIS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1