BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 1901879 · Received November 17, 2010

    Report

    Report Number
    2939301-2010-10077
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Report Date
    November 3, 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

    FOLLOW UP # 1/SUPPLEMENTAL REPORT TEXT-12/06/2010. 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 CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REQUEST ASSISTANCE ON THE HOME CHOICE (HC) MACHINE. PER THE INITIAL REPORT, THE REGISTERED NURSE (RN) WAS INSISTING ON A SWAP BECAUSE THE HOME PATIENT (HP) STATED SHE HAD BEEN FEELING OVERFILLED. THE RN STATED THE HP HAD A HERNIA. THE RN STATED THE FILL VOLUME (FV) IS 2200ML, LAST FILL VOLUME (LFV) 0ML. THE RN STATED THE HP SHOULD BE EMPTY GETTING ON THE HC. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASKED THE RN IF THE HP BYPASSES AND THE RN STATED NO. THE RN STATED THE HP HAD BEEN HAVING ISSUES WITH FIBRIN. THE RN STATED THE HP SHOULD BE USING HEPARIN. THE RN STATED THE FV HAD BEEN INCREASED TO 2200ML AND THAT MIGHT BE THE REASON THE HP WAS FEELING FULL OR OVERFILLED. THE TSR AGREED. THE TSR ASKED THE RN THE TROUBLESHOOTING QUESTIONS AND ASKED THE RN FOR THE THERAPY INFORMATION. THE RN DID NOT HAVE INFORMATION AVAILABLE AT THE TIME OF THE CALL. THE TSR EXPLAINED THE HC WOULD BE SWAPPED. THE RN STATED SHE WOULD ASSIST THE HP WITH PROGRAMMING. ON (B)(4) 2010 PRODUCT SURVEILLANCE CONTACTED THE HP PERITONEAL DIALYSIS NURSE (PDN) REGARDING THE REPORT OF FEELING FULL AND HAVING A HERNIA. THE PDN STATED THE HP HAS RECEIVED THE NEW HC AND WAS DOING GREAT. THE PDN STATED THE HERNIA OCCURRED LAST YEAR AND WAS NOT AN ISSUE. THE PDN STATED THE HP HAS NOT REPORTED ANY SYMPTOMS OR OTHER DRAIN VOLUMES THAT MEET INCREASED INTRAPERITONEAL VOLUME (IIPV) CRITERIA. THE PDN CONFIRMED THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT AND THAT THE HP WAS DOING WELL WITH THE FOLLOWING TREATMENTS. NO ALLEGATIONS WERE MADE AGAINST ANY OF THE HP?S DIALYSIS PRODUCTS. NO FURTHER INFORMATION IS AVAILABLE.

    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 DISPLAY ISSUE 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. 3022081

    Patients

    Seq Age Sex Outcome Treatment
    1