BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 1903968 · Received November 20, 2010

    Report

    Report Number
    2939301-2010-10203
    Event Type
    Malfunction
    Date Received
    November 20, 2010
    Report Date
    November 12, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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; 510(K)# IS K082590.

    Additional Manufacturer Narrative · 1

    FOLLOW UP # 1/SUPPLEMENTAL REPORT TEXT-12/15/2010. 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 BATTERY LEAKAGE. 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

    THIS IS A SPONTANEOUS REPORT BY A PHYSICIAN FROM (B)(6) OF PERITONITIS IN A FEMALE PATIENT COINCIDENT WITH DIANEAL-N PD-4 1.5 THERAPY. ON AN UNREPORTED DATE, THE PATIENT BEGAN PERITONEAL DIALYSIS (PD) THERAPY., (FREQUENCY NOT REPORTED) FOR CHRONIC RENAL FAILURE. ON (B)(6) 2010, THE PHYSICIAN CONFIRMED 2 PINHOLES IN THE TUBE OF THE PATIENT'S UV TRANSFER SET AFTER THE GAUZE THAT COVERED THE EXIT SIT OF THE PATIENT'S UV TRANSFER SET WAS FOUND TO BE WET. . HE EXCHANGED HER TRANSFER SETS. ON AN UNREPORTED DATE, THE PATIENT HAD PERITONITIS. IT WAS REPORTED THAT THE THERE WAS A LEAK FROM THE TWO PINHOLES ON THE TUBING. THE PATIENT GOT PERITONITIS ALTHOUGH THE TUBING WAS CHANGED AFTER THE LEAK OCCURRED. THE PATIENT HAD A HABIT OF PICKING AT THE TUBING WITH HER FINGER SOMETIMES, HOWEVER IT WAS UNSURE IF THERE WAS A RELATION BETWEEN HER HABIT AND THIS EVENT OF PERITONITIS. THE ACTUAL SAMPLE WAS AVAILABLE AND SENT TO BAXTER FOR EVALUATION. THE PATIENT WAS NOT HOSPITALIZED ON (B)(6) 2010, ANTIBIOTICS WERE GIVEN TO THE PATIENT. (IT'S NOT REPORTED WHETHER THE DOSE OF THE ANTIBIOTICS WERE AFTER THE ONSET OF THE PERITONITIS OR NOT) AS OF (B)(6) 2010, THE PATIENT HAD NOT RECOVERED FROM THE EVENT. ON 25NOV2010 AND 26NOV2010, BAXTER RECEIVED ADDITIONAL INFORMATION FROM THE PHYSICIAN AND A NURSE. IT WAS CONFIRMED THAT THE PATIENT STARTED ON (B)(6) 2010, THE PATIENT STARTED ON ANTIBIOTICS (CEFAMEEZIN ALFA AND MODACIN IP(DOSE AND FREQUENCY WERE NOT AVAILABLE THE PHYSICIAN THOUGHT THAT THE EVENT WAS DUE TO THE PINHOLES IN THE TUBE OF THE PATIENT'S UV TRANSFER SET AND NOT RELATED TO DIANEAL N. [FOLLOW-UP INFORMATION WAS RECEIVED ON 25NOV2010 AND 26NOV2010] ON 25NOV2010 ADDITIONAL INFORMATION WAS RECEIVED FROM THE PHYSICIAN AND THE NURSE WHO PROVIDED.. ON (B)(6) 2010, THE PATIENT'S UV TRANSFER SETS WERE EXCHANGED ROUTINELY. ON THE SAME DATE, IN THE AFTERNOON, IT WAS FOUND THAT THE PATIENT'S DIAPER WAS ALSO WET. IT WAS CONFIRMED THAT THE TUBE OF THE PATIENT'S UV TRANSFER SET HAD 2 PINHOLES. THE NURSE OF THE CLINIC EXCHANGED THE PATIENT'S TRANSFER SET. THE PATIENT'S PERITONEAL EFFLUENT CULTURE WAS PERFORMED. CEFAMEZIN ALFA AND MODACIN WERE GIVEN TO THE PATIENT INTRAPERITONEALLY(DOSE UNKNOWN). ON (B)(6) 2010, THE PATIENT HAD PERITONITIS. THE SYMPTOMS WERE; PERITONEAL CLOUDY EFFLUENT, ABDOMINAL PAIN, AND PYREXIA WERE OBSERVED. THE PATIENT WAS IN THE GROUP HOME BEFORE THE EVENT, AND SHE WAS NOT HOSPITALIZED AFTER THE EVENT OCCURRED. ON AN UNREPORTED DATE, HER PERITONEAL EFFLUENT CULTURE RESULTS WERE REVEALED, BUT NO MICRO-ORGANISM WAS IDENTIFIED. ON (B)(6) 2010, ANTIBIOTICS WERE CHANGED TO (B)(6)( THE REPORTER REPORTED AS AN ANTIBIOTIC BRAND NAME) . AS OF (B)(6) 2010, THE PATIENT HAD NOT RECOVERED FROM THE EVENT. HER PD THERAPY WAS ONGOING. THE PHYSICIAN ASSESSED THE PERITONITIS AS NON-SERIOUS. HE THOUGHT THAT THE EVENT WAS DUE TO THE PINHOLES IN THE TUBE OF THE PATIENT'S UV TRANSFER SET AND NOT RELATED TO DIANEAL N. IN THE GROUP HOME, SETTINGS OF THE PATIENT'S PD THERAPY (APD WITH UV ASSIST DEVICE) WERE DONE BY THE GROUP HOME STAFF, AND THERE WAS NO PROBLEM AS TO THEIR ASEPTIC TECHNIQUE. THE NURSE TOLD THAT IT WAS UNLIKELY THE PATIENT DAMAGED HER UV TRANSFER SET. WHEN THE EVENT OCCURRED, THE PATIENT DID NOT HAVE CATHETER EXIT SITE OR TUNNEL INFECTION. THE PATIENT HAD NOT EXPERIENCE ANY PREVIOUS PERITONITIS WITHIN 4 WEEKS OF THE CURRENT EVENT. ON 01DEC2010 ADDITIONAL INFORMATION WAS RECEIVED THAT ON (B)(6) 2010, THE PD EFFLUENT TURNED CLEAR AND ON (B)(6) 2010, THE PATIENT HAD RECOVERED FROM THE EVENT. THE PHYSICIAN ASSESSED THE EVENT AS SERIOUS (HOSPITALIZATION WAS PROLONGED). THE SET HAD BEEN USED FOR 28 DAYS.

    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 POWER BUTTON 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. 2985917

    Patients

    Seq Age Sex Outcome Treatment
    1