BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 1801314 · Received August 16, 2010

    Report

    Report Number
    1823260-2010-04827
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    July 7, 2010
    Report Date
    January 4, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFX
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NEW ADDITIONAL INFORMATION WAS RECEIVED REGARDING PATIENT DEMOGRAPHICS FOR SAMPLES 1-13: SAMPLE 1 WAS A FEMALE, AGE (B)(6). SAMPLE 2 WAS A FEMALE, AGE (B)(6). SAMPLE 3 WAS A FEMALE, AGE (B)(6). SAMPLE 4 WAS A FEMALE, AGE (B)(6). SAMPLE 5 WAS A FEMALE, AGE (B)(6). SAMPLE 6 WAS A FEMALE, AGE (B)(6). SAMPLE 7 WAS A FEMALE, AGE (B)(6). SAMPLE 8 WAS A FEMALE, AGE (B)(6). SAMPLE 9 WAS A FEMALE, AGE (B)(6). SAMPLE 10 WAS A FEMALE, AGE (B)(6). SAMPLE 11 WAS A FEMALE, AGE (B)(6). SAMPLE 12 WAS A FEMALE, AGE (B)(6). SAMPLE 13 WAS A FEMALE, AGE (B)(6).

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF THE INITIAL REPORTER SENT A REPORT TO THE FDA. THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    TWENTY-SIX PATIENT SAMPLES WERE PROVIDED FOR INVESTIGATION. THE INVESTIGATION INCLUDED VERIFICATION OF THE DISCREPANT RUBELLA IGG RESULTS, INTERFERENCE TESTING AND COMPETITOR ASSAY/METHOD TESTING (DIASORIN). TESTING OF THESE SAMPLES CONFIRMED MOST OF THE DISCREPANCIES OBSERVED BY THE CUSTOMER. A THIRD METHOD, DIASORIN, WAS USED TO TEST THE SAMPLES AND GAVE RESULTS SIMILAR TO THE COMPETITOR METHOD RATHER THAN THE ELECSYS. THE ROOT CAUSE IS UNKNOWN. THE TOTAL NUMBER OF PATIENTS INVOLVED IN THE ISSUE IS UNKNOWN. NO ADVERSE EVENTS WERE REPORTED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER PROVIDED TWENTY-SIX ADDITIONAL QUESTIONABLE RUBELLA IGG PATIENT RESULTS WHEN REPEATED ON A COMPETITOR ANALYZER. THIRTEEN RESULTS WERE FOUND TO BE DISCREPANT, ALL UNITS OF MEASURE ARE IU/ML: SAMPLE 1, (B)(6) 2010, INITIAL RESULT 4.63, REPEAT 15. SAMPLE 2, (B)(6) 2010, INITIAL RESULT 9.47, REPEAT 18. SAMPLE 3, (B)(6) 2010, INITIAL RESULT 5.03, REPEAT 17. SAMPLE 4, (B)(6) 2010, INITIAL RESULT 6.47, REPEAT 27. SAMPLE 5, (B)(6) 2010, INITIAL RESULT 9.27, REPEAT 62. SAMPLE 6, (B)(6) 2010, INITIAL RESULT 9.43, REPEAT 21. SAMPLE 7, (B)(6) 2010, INITIAL RESULT 8.41, REPEAT 21. SAMPLE 8, (B)(6) 2010, INITIAL RESULT 7.74, REPEAT 18. SAMPLE 9, (B)(6) 2010, INITIAL RESULT 9.15, REPEAT 20. SAMPLE 10, (B)(6) 2010, INITIAL RESULT 6.58, REPEAT 23. SAMPLE 11, (B)(6) 2010, INITIAL RESULT 8.54, REPEAT 31. SAMPLE 12, (B)(6) 2010, INITIAL RESULT 4.87, REPEAT 15. SAMPLE 13, (B)(6) 2010, INITIAL RESULT 8.02, REPEAT 17. KEY TO RESULT INTERPRETATION- ELECSYS METHOD: <10 IU/ML NON REACTIVE >/=10 IU/ML REACTIVE COMPETITOR METHOD: <10 IU/ML NEGATIVE 10-15 IU/ML INDETERMINATE >15 IU/ML POSITIVE IT IS UNKNOWN IF ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY. NO ADVERSE EVENTS WERE REPORTED.

    Description of Event or Problem · 1

    ELDERLY MALE UNDERGOING AN ENDOSCOPIC VEIN HARVESTING FROM HIS LEG WHEN THE PLASTIC TIP OF THE VEIN HARVESTING SYSTEM BROKE INTO MULTIPLE PIECES IN THE PATIENT'S LEG. THE TUNNEL WAS INSPECTED, THEN IRRIGATED AND SUCTIONED. SEVERAL PIECES OF THE TIP WERE EVACUATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN EXPLORATORY LAPAROTOMY PROCEDURE, THE DEVICE WOULD NOT STAPLE. THE STAPLES WOULD COME OUT, HOWEVER, NOT STAPLE INTO THE SKIN. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE RUBELLA IGG RESULTS FOR THREE PATIENT SAMPLES: PATIENT 1, INITIAL RESULT, TESTED ON THE ANALYTICAL E MODULE, GAVE 7.27 UI/ML. THE REPEAT RESULT, TESTED USING ELFA METHODOLOGY, GAVE 18 UI/ML. PATIENT 2, INITIAL RESULT, TESTED ON THE ANALYTICAL E MODULE ON (B)(6)2010, GAVE 5.77 UI/ML. THE REPEAT RESULT, TESTED USING ELFA METHODOLOGY ON (B)(6)2010 GAVE 21 UI/ML. THIS PATIENT HAD A HISTORY OF RUBELLA INFECTION. PATIENT 3, INITIAL RESULT, TESTED ON THE ANALYTICAL E MODULE ON (B)(6)2010, GAVE 5.98 UI/ML. THE REPEAT RESULT, TESTED USING ELFA METHODOLOGY ON (B)(6)2010 GAVE 21 UI/ML. THIS PATIENT HAD BEEN VACCINATED. REPEAT TESTING USING ELFA METHODOLOGY WAS PERFORMED ON A BIOMERIEUX SYSTEM. KEY TO RESULT INTERPRETATION- ANALYTICAL E MODULE: <10 NON REACTIVE >/=10 REACTIVE BIOMERIEUX (ELFA): <10 NEGATIVE 10-14 INDETERMINATE >/=15 POSITIVE IT IS UNKNOWN IF THE INITIAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY. NO ADVERSE EVENTS HAVE BEEN ALLEGED REGARDING THE DISCREPANCIES. THE RUBELLA IGG REAGENT LOT WAS 156582.

    Description of Event or Problem · 1

    IT APPEARS THE INTRATHECAL PORTION OF THE EPIDURAL CATHETER OF A NEURO STIMULATOR PUMP HAS BROKEN OFF AND IS FREE FLOATING IN THE SPINAL CANAL. NEUROSURGEON FEELS THAT THIS SHOULD BE LEFT ALONE AND NOT REMOVED AT THIS TIME.====================== HEALTH PROFESSIONAL'S IMPRESSION======================PORTION OF CATHETER BROKE OFF AND IS STILL LOCATED IN THE SPINAL CANAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1