BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® ACTIVE TEST STRIPS

    MDR report key: 1860801 · Received October 7, 2010

    Report

    Report Number
    1823260-2010-06001
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Date of Event
    September 30, 2010
    Report Date
    December 1, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K021827
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    AS REPORTED BY THE END USER, DR. (B)(6) USED NANOKNIFE TO TREAT AN OVARIAN LESION, APPROX 1.4CM IN DIAMETER, LOCATED AGAINST THE RECTUM. DR. (B)(6) PERFORMED A HYDRODISSECTION OF THE RECTUM AWAY FROM THE NANOKNIFE PROBES TO PREVENT DAMAGE TO THE RECTUM. A SMALL NEEDLE WAS INSERTED NEAR THE RECTUM TO DELIVER THE D5W USED TO HYDRO-DISSECT THE RECTUM. THE PT HAD A PUDENDAL NERVE INJURY RESULTING IN SEVERE PAIN AND NUMBNESS. THE PT WAS DISCHARGED AFTER AN EIGHT DAY HOSPITAL STAY AND STILL HAD PAIN WHEN SHE LEFT. THE PT IS SCHEDULED FOR A FOLLOW UP VISIT THE WEEK OF THE (B)(6) OF NOVEMBER.

    Description of Event or Problem · 1

    CALLER REPORTED SHE ATE A SANDWICH RIGHT BEFORE TESTING, HAD ACTIVE SYSTEM RESULTS OF 323 MG/DL, 180 MG/DL, AND 146 MG/DL WITHIN 10 MINUTES. REPORTED NO ADVERSE EVENT RELATIVE TO DISCREPANCY. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS, REPLACEMENT SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® ACTIVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS 22998332

    Patients

    Seq Age Sex Outcome Treatment
    1 063 YR DIOVAN 1XDAY| SYNTHROID 1XDAY| ASACOL| ACTOS 1XDAY| VITAMIN D3 1XDAY| NAPROXEN 2XDAY| NOVOLOG 70/30 2XDAY| SIMVASTATIN 1XDAY| METFORMIN