BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    H/ CREATININE + R1 (D,P)

    MDR report key: 3230074 · Received July 16, 2013

    Report

    Report Number
    1823260-2013-04292
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Date of Event
    June 23, 2013
    Report Date
    May 8, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JFY
    PMA / PMN Number
    K953239
    Removal / Correction Number
    1823260-04/30/15-003-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURED IN (B)(6). FOR THE MEDWATCH ON MOD1, REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6).

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THIS EVENT HAS DETERMINED THAT RESULTS MAY BE FALSELY DECREASED WHEN THE TEST IS RUN WITH URINE OR BLOOD SAMPLES COLLECTED BEFORE SUFFICIENT TIME HAS LAPSED AFTER THE ADMINISTRATION OF THE DRUGS ACETAMINOPHEN AND N-ACETYLCYSTEINE. THE "LIMITATIONS-INTEFERENCE" SECTION OF THE TEST METHOD SHEET IS BEING UPDATED TO INCLUDE CLAIMS WHICH DESCRIBE THE OBSERVED DIFFERENCES IN RELATION TO THE INTERFERING DRUG OR ITS METABOLITES. UNTIL THE NEW METHOD SHEET IS AVAILABLE, A NOTICE HAS BEEN SENT TO CUSTOMERS SERVING AS UPDATED LABELING.

    Additional Manufacturer Narrative · 1

    EVEN AT HIGH CONCENTRATIONS, ACETAMINOPHEN DOES NOT INTERFERE WITH THE CREA PLUS ASSAY. THE ACETAMINOPHEN METABOLITE N-ACETYL BENZOCHINONEIMIN (NAPQI) DOES INTERFERE WITH THE CREA PLUS ASSAY. THE DIFFERENCES IN THE SAMPLE RESULTS WHICH WERE OBSERVED CAN BE EXPLAINED AS THE INTERFERENCE OF NAPQI AS WELL AS WITH THE INSTABILITY OF THIS INTERFERENCE. THE LONGER THE SAMPLE WAS IN THE TUBE, THE SMALLER WAS THE DIFFERENCE OF CREA PLUS COMPARED TO THE ABL METHOD.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE CREATININE PLUS (CREP) RESULTS FOR ONE PATIENT ON THEIR P-MODULE (MOD2). THE UNITS OF MEASURE FOR THE CREP RESULTS WERE REQUESTED BUT NOT PROVIDED. THE CUSTOMER STATED THAT ON THE DAY OF THE EVENT, THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT DUE TO VERY HIGH LEVELS OF ACETAMINOPHEN. THE PATIENT HAD A BLOOD SAMPLE TESTED SAMPLE (SAM1) TESTED ON ANOTHER P- MODULE (MOD1), AND THE CREP RESULT WAS 42. THE SAMPLE WAS TESTED ON A SECOND P-MODULE (MOD2) AND ALL THE ASSAYS INCLUDING CREP WERE REPEATED. THE CREP RESULT WAS 70, AND ALL OTHER TESTS WERE COMPARABLE. ONE OF THE MODULAR CREP RESULTS WAS REPORTED TO THE REQUESTING DEPARTMENT. SIX MINUTES LATER, THE ICU TESTED ANOTHER SAMPLE ON AN ABL ANALYZER, AND THE CREP RESULT WAS 197. THAT EVENING, ANOTHER SAMPLE (SAM2) WAS DRAWN AND TESTED. THE CREP RESULT FROM MOD1 WAS 7. THE CREP RESULT FROM MOD2 WAS 11. THE CREP RESULT FROM THE ABL WAS 187. THE CUSTOMER THEN ANALYZED 10 SAMPLES FROM DIFFERENT PATIENTS ON ALL THREE INSTRUMENTS AND ALL THE REPEAT RESULTS WERE COMPARABLE. ON (B)(6) 2013, THE PATIENT HAD ANOTHER SAMPLE DRAWN (SAM4). THE CREP RESULT FROM ONE OF THE P-MODULES WAS 58. THE RESULT FROM THE ABL WAS 200. ON (B)(6) 2013, THE CUSTOMER TOOK SAM1 AND SAM2 FROM THE DAY BEFORE, A SAMPLE (SAM3) THAT WAS USED FOR OTHER TESTS, AND SAM4 FOR REPEAT TESTING. THE SAMPLES WERE TESTED ON ONE OF THE P-MODULES AND THE ABL. THE CREP RESULT OF SAM1 ONE OF THE P-MODULES WAS 208. THE RESULT FROM THE ABL WAS 218. THE CREP RESULT OF SAM2 ONE OF THE P-MODULES WAS 206. THE RESULT FROM THE ABL WAS 218. THE CREP RESULT OF SAM3 ONE OF THE P-MODULES WAS 173. THE RESULT FROM THE ABL WAS 198. THE CREP RESULT OF SAM4 ONE OF THE P-MODULES WAS 181. THE RESULT FROM THE ABL WAS 246. THE PATIENT LATER DIED FROM ACETAMINOPHEN POISONING. THERE WAS NO ALLEGATION THAT THE DISCREPANT CREP RESULTS CONTRIBUTED TO THE PATIENT DYING. THERE WERE NO REPORTS OF ANY ADVERSE AFFECTS TO THE PATIENT FROM THIS EVENT. THE CREP R1 REAGENT LOT NUMBER WAS 683067. THE CREP R2 REAGENT LOT NUMBER WAS 680503. THE EXPIRATION DATES WERE REQUESTED BUT NOT PROVIDED. THE CUSTOMER ONLY PROVIDED A SERIAL NUMBER OF (B)(4) FOR ONE ANALYZER. IT WAS UNCLEAR IF THE SERIAL NUMBER CORRESPONDED TO MOD1 OR MOD2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328380 H/ CREATININE + R1 (D,P) ENZYMATIC METHOD, CREATININE JFY ROCHE DIAGNOSTICS NA 683067

    Patients

    Seq Age Sex Outcome Treatment
    1 062 YR METAOXIDRIN| THIAMIN| BERODUAL| SERETIDE| B-COMBIN| NAC| NOVA RAPID| KONATION