BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROCHE CARDIAC D-DIMER 10 TESTS

    MDR report key: 2506114 · Received March 27, 2012

    Report

    Report Number
    1823260-2012-01626
    Event Type
    Malfunction
    Date Received
    March 27, 2012
    Date of Event
    February 29, 2012
    Report Date
    May 22, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GHH
    PMA / PMN Number
    K033491
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2012, ADDITIONAL RESULTS FOR THE PATIENT FROM AN EXTERNAL LABORATORY WERE RECEIVED: D-DIMER: 9.91 UG/ML TROPONIN I: < 0.03 NG/ML BNP: 63 NG/L THE UNIT MEASURE FOR THE D-DIMER RESULTS FROM (B)(6) 2012 REPORTED IN THE PREVIOUS SUPPLEMENTAL MEDWATCH WAS UG/ML, NOT MG/ML. ADDITIONAL INFORMATION WAS RECEIVED STATING THE PATIENT DID NOT TAKE DRUGS REGULARLY BEFORE THE HOSPITALIZATION. BECAUSE OF HYPERTENSION, ACEMIN WAS PRESCRIBED. PATIENT USED ACEMIN UNTIL THE LAST CHECKUP.

    Additional Manufacturer Narrative · 1

    A SAMPLE FROM THE PATIENT WAS PROVIDED FOR INVESTIGATION AND A CLEAR PRESENCE OF HETEROPHILIC ANTIBODIES WAS INDICATED. THE INTERFERENCE OF THESE ANTIBODIES IS DESCRIBED IN PRODUCT LABELING.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED: (B)(6). PATIENT HAD A BMI OF (B)(6). ON (B)(6) 2012, THREE SAMPLES WERE MEASURED WITH DIFFERENT INSTRUMENTS AT THE SAME SITE. THE RESULTS WERE 0.44 UG/ML AND 0.46 UG/ML. THE PATIENT WAS TESTED AGAIN ON (B)(6) 2012 AND HAD D-DIMER RESULT OF 40 UG/ML (MEASURED ON COBAS INTEGRA 400), 0.29 UG/ML (MEASURED ON COBAS H 232) AND PROBNP 4204 PG/ML. ON (B)(6) 2012, SHE HAD ALSO ELEVATED TROPONIN T (276 NG/L) AND PROBNP (2677 PG/ML) LEVELS (BOTH MEASURED WITH COBAS H 232). THE HOSPITAL "MADE SEVERAL TESTS TO CLARIFY THE DIAGNOSIS (E.G. KIDNEY ANGIOGRAPHY)". THE HOSPITAL COULD NOT MAKE A FINAL DIAGNOSIS AND THE PATIENT WAS REFERRED TO THE CARDIOLOGIC DEPARTMENT. THE RESULT FROM THE COBAS H232 WAS CANCELLED AND THE RESULT FROM THE INTEGRA 400 ANALYZER WAS REPORTED OUTSIDE THE LABORATORY. THE PATIENT WAS NOT ADVERSELY AFFECTED AND IS WELL. THE PATIENT IS COMPETITIVE ATHLETE AND WAS AT THE HOSPITAL FOR A PERFORMANCE EVALUATION. "THE PATIENT ORIGINALLY CAME TO HOSPITAL BECAUSE OF A DECREASE OF PERFORMANCE AND SHOWED PALPITATIONS. SHE STOPPED TRAINING, NEVERTHELESS HAD AN INCREASE OF PROBNP FROM 2677 PG/ML TO 4204 PG/ML IN 3 WEEKS. AS SHE FEELS COMPLETELY WELL, SHE STARTED WITH THE TRAINING AGAIN. HEART MRT WAS WITHOUT RESULT."

    Additional Manufacturer Narrative · 1

    ADDITIONAL RESULTS WERE PROVIDED FOR THE PATIENT: (B)(6) 2012: PRO BNP-2843 PG/ML TROPONIN T -199 NG/L (B)(6) 2012: PRO BNP-2597 PG/ML D-DIMER -83.00 UG/ML (B)(6) 2012: TROPONIN T -246 NG/L D-DIMER -79.00 UG/ML (B)(6) 2012: D-DIMER -74.60 UG/ML TROPONIN T -161 NG/L UNKNOWN DATE: TROPONIN T -275 NG/L AND 191NG/L ON (B)(6) 2012, THE PATIENT WAS RETESTED WITH THE FOLLOWING RESULTS: COBAS H 232 SERIAL NUMBER (B)(4) WITH STRIP LOT NUMBER 2807881: D- DIMER RESULT WAS 0.54 MG/ML. COBAS H 232 SERIAL NUMBER (B)(4) WITH STRIP LOT NUMBER 2807881: D- DIMER RESULT WAS 0.49 MG/ML. THE INTEGRA 400 D-DIMER RESULT WAS > 54.5 MG/ML. COBAS H 232, SERIAL NUMBER (B)(4) WITH STRIP LOT NUMBER 28074610: PROBNP RESULT WAS 3450 PG/ML. COBAS H 232 SERIAL NUMBER (B)(4) WITH STRIP LOT NUMBER 28074610: PROBNP RESULT WAS 3963 PG/ML COBAS H 232 SERIAL NUMBER (B)(4) WITH STRIP LOT NUMBER 28075120: TROPONIN-T RESULT WAS 193 NG/L. COBAS H 232 SERIAL NUMBER (B)(4) WITH STRIP LOT NUMBER 28075120: TROPONIN-T RESULT WAS 291 NG/L. NO INFORMATION WAS PROVIDED TO DETERMINE IF ANY ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY OR IF THE PATIENT WAS ADVERSELY AFFECTED.

    Description of Event or Problem · 1

    THE RECEIVED A QUESTIONABLE D-DIMER RESULT FROM THE COBAS H232 METER. THE INITIAL RESULT WAS 0.42 UG/ML. THE PATIENT HAD SYMPTOMS SO THEY DECIDED TO ANALYZE THE SAMPLE IN THE LABORATORY ON AN INTEGRA 400 PLUS ANALYZER. THE INTEGRA GAVE A RESULT OF "HIGH ACTIVITY" SO THE CUSTOMER DILUTED THE SAMPLE AND MEASURED IT AGAIN ON THE INTEGRA 400 AND STILL DID NOT RECEIVE A RESULT. THEY THEN DILUTED THE PATIENT SAMPLE MANUALLY (1:10) AND TESTED IT AGAIN ON THE COBAS INTEGRA 400 AND RECEIVED A RESULT OF 80 UG/ML. IT WAS UNKNOWN IF THE ERRONEOUS RESULT WAS REPORTED OUTSIDE THE LABORATORY OR IF THE PATIENT WAS ADVERSELY AFFECTED. THE CUSTOMER RAN QUALITY CONTROL ON THE COBAS H 232, WHICH WAS ACCEPTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROCHE CARDIAC D-DIMER 10 TESTS FIBRINOGEN/FIBRIN DEGRADATION PRODUCTS ASSAY GHH ROCHE DIAGNOSTICS NA 28049116

    Patients

    Seq Age Sex Outcome Treatment
    1 027 YR