BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 1626115 · Received March 10, 2010

    Report

    Report Number
    1823260-2010-01510
    Event Type
    Malfunction
    Date Received
    March 10, 2010
    Date of Event
    February 15, 2010
    Report Date
    April 9, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFX
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. CALIBRATION AND QC DATA ARE WITHIN EXPECTED RANGES. THE CUSTOMER SUSPECTED A POSSIBLE BUBBLE IN THE SAMPLE AS THEY DID NOT EXPERIENCE ADDITIONAL EVENTS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    FROM LITERATURE: LANGREHR, JAN M.; SCHMIDT, SVEN CHRISTIAN. SPRAY APPLICATION OF FIBRIN GLUE AS RISK FACTOR FOR SUBCUTANEOUS EMPHYSEMA IN LAPAROSCOPIC TRANSABDOMINAL INGUINAL HERNIA REPAIR. SURGICAL LAPAROSCOPY ENDOSCOPY & PERCUTANEOUS TECHNIQUES. 17(3): 221-222, JUNE 2007. A (B)(6) PATIENT WHO UNDERWENT LAPAROSCOPIC TRANSABDOMINAL REPAIR OF A LEFT-SIDED COMBINED INDIRECT/DIRECT GROIN HERNIA. AFTER UNEVENTFUL INTUBATION, CO2 INSUFFLATION OF THE ABDOMEN WAS PERFORMED WITH A PRESSURE OF 14MM HG. THREE TROCARS WERE PLACED. AFTER DISSECTION OF THE HERNIA SAC AND CREATION OF A LARGE PREPERITONEAL SPACE, THE HERNIA DEFECT WAS COVERED WITH A 10 15 CM VYPRO II MESH (ETHICON (B)(4)). FOR MESH FIXATION, 2ML OF FIBRIN GLUE WAS SPRAYED OVER THE MESH. DURING THIS PROCEDURE, AN INTRA-ABDOMINAL PEAK PRESSURE OF 30MM HG WAS NOTICED. AFTER IMMEDIATE DESUFFLATION OF THE ABDOMEN, WE CONTINUED TO SPRAY THE FIBRIN BUT OPENED A TROCAR FOR PRESSURE BALANCE. THERE WAS NO RISE OF THE END TIDAL CO2 DURING THE ENTIRE OPERATION (RANGE, 4.4 VOL%-4.8 VOL%). THE OXYGEN SATURATION WAS 100%. AT THE FIRST POSTOPERATIVE DAY, A SUBCUTANEOUS EMPHYSEMA OF THE ABDOMINAL WALL WAS NOTICED AS CREPITUS AT THE PHYSICAL EXAMINATION. THE PATIENT DID NOT COMPLAIN ABOUT CHEST PAIN OR DYSPNEA. AFTER AN OTHERWISE UNEVENTFUL RECOVERY, THE PATIENT WAS DISCHARGED AT POSTOPERATIVE DAY 3 AND AT A FOLLOW-UP APPOINTMENT 8 DAYS LATER, THE ABDOMINAL WALL CREPITUS WAS NEARLY COMPLETE RESOLVED. FOLLOW-UP WITH DR. (B)(6), ON (B)(6) 2010 IDENTIFIED THE DEVICE USED AS TISSOMAT.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A NEGATIVE RUBELLA IGG RESULT OF 2.62 IU/ML FOR ONE PATIENT SAMPLE. A SECOND SAMPLE WAS TAKEN AND MEASURED ALONG WITH THE FIRST SAMPLE ON (B) (6) 2010 AND BOTH SAMPLES GAVE A POSITIVE RESULT. THE ORIGINAL SAMPLE GENERATED A RESULT OF 106.7 IU/ML AND THE NEW SAMPLE GENERATED A RESULT OF 105.5 IU/ML. THE CUSTOMER BELIEVED THE NEGATIVE RESULT OF 2.62 IU/ML WAS INCORRECT. THE ERRONEOUS RESULT WAS NOT REPORTED TO THE PATIENT. THE RUBELLA IGG REAGENT LOT NUMBER WAS 155388.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANALYTICAL E MODULE IMMUNOCHEMISTRY ANALYZER LFX ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1