BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 1883686 · Received October 27, 2010

    Report

    Report Number
    2939301-2010-09518
    Event Type
    Malfunction
    Date Received
    October 27, 2010
    Report Date
    October 24, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP # 1/SUPPLEMENTAL REPORT TEXT-12/01/2010. 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 A LOW/DEAD BATTERY. 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

    NOTE: THIS MFR REPORT PERTAINS TO ONE OF TWO DEVICES THAT WERE USED DURING THE SAME PROCEDURE. MFR REPORT #3005099803-2010-04950 ADDRESSES THE OTHER DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A INJECTION GOLD PROBE DEVICE AND RADIAL JAW 4 LC - BIOPSY FORCEPS DEVICE WERE USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE EGD PROCEDURE, THE PHYSICIAN TOOK A BIOPSY USING A RADIAL JAW 4 LC - BIOPSY FORCEPS, AND THE PATIENT HAD SOME BLEEDING FROM THE TISSUE THAT REQUIRED THERMAL CARE. THEY WENT TO USE AN INJECTION GOLD PROBE DEVICE, BUT IT WOULD NOT CONDUCT ANY ENERGY. THE BLEED WAS TREATED WITH THE SAME GENERATOR AND CABLE, ALONG WITH A SECOND INJECTION GOLD PROBE DEVICE. THE PROCEDURE WAS COMPLETED WITH THIS RADIAL JAW 4 LC - BIOPSY FORCEPS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT'S CONDITION WAS REPORTED TO BE FINE.

    Description of Event or Problem · 1

    THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING A BATTERY INDICATOR ISSUE WITH THE METER. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WERE NO ALLEGATIONS OF HARM OR INJURY. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 3052227

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR