BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D-DIMER

    MDR report key: 2192606 · Received August 5, 2011

    Report

    Report Number
    1823260-2011-04211
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    June 16, 2011
    Report Date
    October 20, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GHH
    PMA / PMN Number
    K033491
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION OF THE PATIENT SAMPLE, TEST ASSAY, PIPETTE, AND DEVICE COULD NOT BE PERFORMED AS NO MATERIALS WERE RETURNED FOR INVESTIGATION RETENTION TESTING WAS PERFORMED ON REAGENT FROM THE SAME LOT AND WAS WITHIN SPECIFICATION. ALL PRODUCT CLAIMS WERE MET. THE PHYSICIAN DID NOT ONLY RELY UPON THE RESULTS OF THE D-DIMER TEST FOR DIAGNOSIS. BASED UPON CLINICAL SYMPTOMS, A CT SCAN OF THE LUNG WAS PERFORMED AND THE PULMONARY EMBOLISM WAS DIAGNOSED. IMAGERY REPRESENTATION OF PULMONARY EMBOLISM WITH CT SCAN IS ENOUGH TO DIAGNOSE AND TO PERFORM TREATMENT WHEN THE PATIENT IS IN CRITICAL CONDITION AND SYMPTOMS ARE PRESENT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A PATIENT WAS ADMITTED TO THE EMERGENCY ROOM IN (B)(6) WITH SYMPTOMS AT 11:30 AM. THE SYMPTOMS OF THE PATIENT WERE REQUESTED BUT NOT PROVIDED. THE PATIENT'S BLOOD WAS DRAWN AND TESTED FOR D-DIMER USING THE ROCHE H232 INSTRUMENT (SERIAL NUMBER NOT PROVIDED). THE RESULT OF THE D-DIMER TEST WAS 0.4 UG/ML, WHICH IS CONSIDERED NEGATIVE. THIS TEST WAS PERFORMED AT APPROXIMATELY 12 PM. THESE RESULTS DID NOT CORRELATE WITH THE PATIENT'S SYMPTOMS. THE PHYSICIAN BELIEVED THE PATIENT SUFFERED FROM AN EMBOLISM AND ORDERED A CT SCAN TO CONFIRM THE DIAGNOSIS. THE TIME OF THE CT SCAN WAS NOT PROVIDED. THE CT SCAN SHOWED "THE EMBOLI CLOT IN THE PATIENT." FOLLOWING THE RESULTS OF THE CT SCAN, THE PATIENT WAS TREATED. CATECHOLAMINES WERE ADMINISTERED AND ANTICOAGULATION WITH HEPARIN WAS PERFORMED. THE TIME TREATMENT WAS ADMINISTERED HAS BEEN REQUESTED BUT HAS NOT BEEN PROVIDED. AT 3:00 PM, THE PATIENT WAS MOVED TO THE INTENSIVE CARE UNIT. A SECOND SAMPLE FROM THE PATIENT, DRAWN AT THE SAME TIME AS THE SAMPLE TESTED ON THE H232, WAS SENT TO THE CENTRAL LAB FOR TESTING USING AN AUTOMATED INSTRUMENT, A SYSMEX CA1500. THE D-DIMER RESULT FROM THIS ANALYZER WAS RETURNED APPROXIMATELY 4 HOURS LATER. THE RESULT WAS 9946 MCG/L. THIS ADDITIONAL TESTING WAS PERFORMED BECAUSE THE LABORATORY HAS A STANDARD OPERATING PROCEDURE TO RE-CHECK D-DIMER RESULTS. THE PATIENT DIED AT 5:00 PM THE SAME DAY. BELOW PLEASE FIND A SUMMARY OF THE TIMELINE OF EVENTS RELATED TO THE PATIENT: 11:30 A.M. THE PATIENT WAS ADMITTED TO THE ER 12:00 P.M. D-DIMER RESULT FROM THE H232 ANALYZERS WAS 0.4 MCG/UL 12:00 P.M. SECOND SAMPLE SENT FOR D-DIMER TESTING USING THE CA 1500 00:17 P.M. TROPONIN T RESULT FROM THE H232 ANALYZER WAS 0.03-0.1 00:54 P.M. CK-MB RESULT FROM AN COBAS INTEGRA 400 WAS 2.2 NG/ML 1:20 P.M. PT RESULT WAS 33.6 SECONDS 2:22 P.M. BGA RESULTS INDICATE SEVERE ACIDOSIS , HYPERCAPNIA 3:00 P.M. PATIENT ADMITTED TO ICU 3:10 P.M. PTT RESULT WAS 196.5 SECONDS 3:38 P.M. BGA RESULTS NEARLY UNCHANGED 3:52 P.M. RESULT FROM THE CA 1500 IS REPORTED AS 9946 MCG/L 5:00 P.M PATIENT PASSED AWAY. IN ADDITION TO THE D-DIMER TEST, THE PHYSICIAN ALSO ORDERED A CT SCAN BE PERFORMED ON THE PATIENT. THE PHYSICIAN ACTED ON THE SYMPTOMS AND CLINICAL SIGNS AND PERFORMED A CT SCAN DESPITE THE NEGATIVE D-DIMER RESULT AND THE PULMONARY EMBOLISM WAS DIAGNOSED. THE PHYSICIAN DID NOT RELY ONLY UPON THE D-DIMER TEST RESULT FOR DIAGNOSIS OF THE PATIENT. BASED UPON CLINICAL SYMPTOMS, HE PERFORMED A CT OF THE LUNG. IMAGERY REPRESENTATION OF A PULMONARY EMBOLISM WITH CT IS ENOUGH TO DIAGNOSE AND PERFORM TREATMENT, PARTICULARLY WHEN THE PATIENT IS IN CRITICAL CONDITION AND PRESENTS WITH SYMPTOMS. CATECHOLAMINES WERE ALSO ADMINISTERED AND ANTICOAGULATION WITH HEPARIN WAS PERFORMED. THE ANTICOAGULATION WAS EARLY AND SUFFICIENT AS THE PTT TWO AND A HALF HOURS AFTER ADMISSION WAS 196.5 SECONDS. THE BGA OF THE PATIENT 3 HOURS AFTER ADMISSION DEMONSTRATE THE ACUTE CONDITION THE PATIENT WAS IN. AN ACIDOSIS OF 7, 012 PH WITH A BE OF - 16 SELDOM IS SURVIVED AND MOSTLY FOLLOWED BY SEVERE ARRHYTHMIAS AND CARDIAC ARREST. THE PATIENT WAS TRANSFERRED TO ICU 40 MINUTES AFTER THE INITIAL BGA TESTING WAS PERFORMED. FORTY MINUTES LATER, A SECOND BGA WAS NEARLY UNCHANGED, PRESUMABLY DUE TO GLOBAL RESPIRATORY INSUFFICIENCY AND REDUCE LUNG SURFACE FOR OXYGEN EXCHANGE. THE HYPERCAPNIA ALSO WORSENED THE ACIDOSIS. TWENTY MINUTES AFTER THE SECOND BGA, THE PATIENT PASSED AWAY. ADDITIONAL INFORMATION REGARDING THE PATIENT, SUCH AS GENDER, AGE, RISK FACTORS, OTHER MEDICATIONS, AND MEDICAL HISTORY WERE REQUESTED. THE CUSTOMER WILL NOT PROVIDE ANY ADDITIONAL INFORMATION REGARDING THE PATIENT DUE TO CONFIDENTIALITY CONCERNS. ON (B)(6) 2011, FIELD SERVICE PERSONNEL VISITED THE SITE TO CHECK THE QUALITY CONTROL. BOTH LEVELS OF QUALITY CONTROL WERE ACCEPTABLE. THE H232 INSTRUMENT, REMAINING CARDIAC D-DIMER STRIPS, AND THE USED D-DIMER STRIPS HAVE BEEN REQUESTED FOR INVESTIGATION. MEASUREMENTS HAVE BEEN PERFORMED ON RETENTION MATERIALS AND WERE WITHIN SPECIFICATION. INVESTIGATION OF THIS EVENT IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 D-DIMER FIBRIN SPLIT PRODUCTS GHH ROCHE DIAGNOSTICS NA 280152

    Patients

    Seq Age Sex Outcome Treatment
    1 HEPARIN 5000 UNITS/ML| KAPPA TABLET| ATROPINE INJECTION| ADRENARINE INJECTION| SODIUM BICARBONATE INJECTION| LEVOPHED INJECTION| DOPAMINE| CHLORHEXIDINE 2% IN 70% ALCOHOL| HIBITANE