BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 1860877 · Received October 7, 2010

    Report

    Report Number
    2939301-2010-08918
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Report Date
    October 4, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510 (K) IS K082590.

    Additional Manufacturer Narrative · 1

    FOLLOW UP # 1/SUPPLEMENTAL REPORT TEXT 11/09/2010. THE LAY USER/PATIENT'S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE HAS PASSED TESTING WITH NO FAULTS FOUND. HOWEVER A SECONDARY ISSUE WAS NOTED AS LCD CRACKED/BROKEN. 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'S RELATIVE CONTACTED LIFESCAN ALLEGING THE METER DOES NOT POWER ON. 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

    DURING FOLLOW-UP FOR AN UNRELATED ALARM, THE PATIENT INDICATED SHE HAS HAD INFECTIONS BUT WAS NOT SURE OF THE DATES. THE PATIENT STATED THAT SHE HAD HER CATHETER CHANGED BECAUSE OF THE INFECTIONS. ON 10/19/2010, THE PATIENT'S NURSE INDICATED THE FOLLOWING INFORMATION: ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 AMBUFLEX AND NUTRINEAL PD4 UNKNOWN BAG THERAPY (DOSES, FREQUENCIES AND LOT NUMBERS WERE NOT REPORTED) INTRAPERITONEALLY (IP) FOR AMBULATORY PERITONEAL DIALYSIS (APD). DURING A FOLLOW-UP CALL WITH BAXTER TECHNICAL SERVICE CENTER REGARDING AN ALARM ON THE HOMECHOICE DEVICE AND THE REPORTED EVENTS OF "INFECTIONS", THE FOLLOWING INFORMATION WAS OBTAINED. ON (B)(6) 2010, THE PATIENT EXPERIENCED PERITONITIS AND WAS TREATED WITH AN UNKNOWN COURSE OF ANTIBIOTIC THERAPY. LABORATORY EXAMINATIONS PERFORMED FOR THIS EPISODE OF PERITONITIS WERE NOT REPORTED. ON (B)(6) 2010, THE PATIENT AGAIN EXPERIENCED AN EPISODE OF PERITONITIS. ON THAT SAME DATE, A PERITONEAL EFFLUENT ANALYSIS AND CULTURE WERE PERFORMED PRIOR TO THE START OF ANTIBIOTICS. THE ANALYSIS REVEALED TOTAL NUCLEAR CELLS 640, MONONUCLEARS 0.11, POLYNUCLEARS 0.79, AND NON-HAEM CELL 0.10. THE RESULT OF THE CULTURE WAS (B)(6). THE PATIENT WAS TREATED WITH AN UNKNOWN COURSE OF ANTIBIOTIC THERAPY. ON (B)(6) 2010, THE PATIENT WAS HOSPITALIZED FOR A CATHETER EXCHANGE AND WAS DISCHARGED ON (B)(6) 2010. THE PATIENT WAS NEVER HOSPITALIZED FOR PERITONITIS. ON (B)(6) 2010, THE PATIENT EXPERIENCED HER THIRD EPISODE OF PERITONITIS. ON THAT SAME DATE, A PERITONEAL EFFLUENT ANALYSIS WAS PERFORMED. THE ANALYSIS REVEALED TOTAL NUCLEAR CELLS 250, MONONUCLEARS 0.67, AND POLYNUCLEARS 0.33. ON AN UNREPORTED DATE, DURING ONE OF THE EPISODES OF PERITONITIS, A PERITONEAL EFFLUENT CULTURE REVEALED "EPIDERMIDIS." THE REPORTING NURSE INDICATED THAT ON ONE PREVIOUS TREATMENT FOR PERITONITIS, THE PATIENT WAS GIVEN VANCOMYCIN, BUT WAS UNABLE TO CONFIRM FOR WHICH EPISODE OR PROVIDE DETAILS REGARDING DOSE, FREQUENCY, ROUTE OR DURATION. ON (B)(6) 2010, THE PATIENT BEGAN A THREE WEEK COURSE OF REMEDIAL THERAPY WITH CEFTAZIDIME (1000MG, DAILY, IP) WHICH WAS COMPLETED ON (B)(6) 2010. THE RECURRENT PERITONITIS WAS RESOLVING. THE NURSE STATED THAT THE PERITONITIS WAS CAUSED BY A BREAK IN ASEPTIC TECHNIQUE DESCRIBED AS POOR TECHNIQUE OF CONNECTION AND DISCONNECTION. IT WAS NOT REPORTED WHETHER THE PATIENT WAS RETRAINED IN ASEPTIC TECHNIQUE. IT WAS UNKNOWN WHETHER THE DIANEAL PD4 AMBUFLEX AND NUTRINEAL PD4 UNKNOWN BAG THERAPY WERE ONGOING. THE REPORTING NURSE BELIEVED THAT THE RECURRENT PERITONITIS WAS NOT RELATED TO DIANEAL PD4 AMBUFLEX AND NUTRINEAL PD4 UNKNOWN BAG THERAPIES BUT WAS CAUSED BY THE POOR TECHNIQUE OF CONNECTION AND DISCONNECTION. THE REPORTER FURTHER STATED THAT THE PREVIOUS BACTERIA IDENTIFIED WAS EPIDERMIDIS WHICH DENOTED CONTAMINATION OR CONTACT BACTERIA. THE REPORTER DID NOT PROVIDE A CAUSALITY STATEMENT FOR THE EVENT OF POOR TECHNIQUE OF CONNECTION AND DISCONNECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 3041660

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR