BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP DIGOXIN (DIG) ASSAY

    MDR report key: 5480668 · Received March 4, 2016

    Report

    Report Number
    1219913-2016-00046
    Event Type
    Malfunction
    Date Received
    March 4, 2016
    Date of Event
    January 27, 2016
    Report Date
    October 26, 2016
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    KXT
    PMA / PMN Number
    K931213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2016-00046 ON 03/04/2016 FOR A FALSE HIGH ADVIA CENTAUR XP DIGOXIN (DIG) RESULT OBTAINED ON A PATIENT SAMPLE. ON 03/16/2016 ADDITIONAL INFORMATION: THE PATIENT SAMPLE WAS RETURNED AND TESTED ON THE ADVIA CENTAUR XP DIGOXIN ASSAY. THE SAMPLE WAS RUN NEAT, 1:2 DILUTION, HETEROPHILIC BLOCKING TUBE (HBT), AND 1:2 DILUTION WITH A HBT TUBE. ALL THE RESULTS WERE >5.0 NG/ML. THE RESULTS INDICATE THERE IS AN INTERFERENT THAT IS NOT ATTRIBUTED TO NON-SPECIFIC BINDING, AND INCONCLUSIVE FOR THE INTERFERENCE FROM HETEROPHILIC AND/OR NON-SPECIFIC BINDING ANTIBODIES, HOWEVER ANOTHER SAMPLE WILL BE PROVIDED FOR FURTHER TESTING. PATIENT MEDICATIONS: ACETAMINOPHEN, ALBUTEROL (PROVENTIL), ALPRAZOLAM, ASPIRIN, ASPIRIN EC (HALFPRIN), DIGOXIN IMMUNE F (DIGIFAB), DILTIAZEM (CARDIZEM), FAMOTIDINE (PEPCID), FLUTICASONE-SALMETEROL, FUROSEMIDE (LASIX), LISINOPRIL (PRINIVIL ZESTRIL), METOPROLOL SUCCINATE (TOPROL-XL), NITROGLYCERINE, OMEPRAZOLE (PRILOSEC), PANTOPRAZOLE (PROTONIX), PNEUMOCOCCAL 13-VALENT CONJUGATE VACCINE, PRAVASTATIN, RANITIDINE (ZANTAC), 0.9% SODIUM CHLORIDE FLUSH INJECTION, TRAMADOL (ULTRAM), WARFARIN (COUMADIN).

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2016-00046 ON 03/04/2016 FOR A FALSELY ELEVATED ADVIA CENTAUR XP DIGOXIN RESULT , AND MDR 2120016-2016-00046 SUPPLEMENTAL REPORT 1 FOR ADDITIONAL INFORMATION. ON 04/20/2016 ADDITIONAL INFORMATION: THE CUSTOMER PROVIDED A SECOND PATIENT SAMPLE FOR FURTHER DIGOXIN TESTING BY SIEMENS. THE SAMPLE WAS TESTED ON AN ADVIA CENTAUR XP, AND ON THREE OTHER ALTERNATE DIGOXIN TEST METHODS. THE ADVIA CENTAUR XP RESULTS WERE OBSERVED TO BE FALSELY ELEVATED COMPARED TO THE ALTERNATE DIGOXIN TEST METHOD RESULTS, AND MAY BE ATTRIBUTED TO AN UNKNOWN INTERFERING SUBSTANCE. SIEMENS HAS REQUESTED ADDITIONAL PATIENT INFORMATION. TEST RESULTS: (B)(6).

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE FALSE HIGH ADVIA CENTAUR XP DIGOXIN TEST RESULTS IS UNKNOWN. THE CUSTOMER'S QUALITY CONTROL RESULTS WERE WITHIN ACCEPTABLE RANGES AT THE TIME OF THE EVENT, AND THE CUSTOMER HAS PREVIOUSLY PASSED A CAP SURVEY FOR UNKNOWNS, AND LINEARITY TESTING. SIEMENS IS INVESTIGATING. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATION.

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2016-00046 ON 03/04/2016 FOR A FALSELY ELEVATED ADVIA CENTAUR XP DIGOXIN RESULT, MDR 2120016-2016-00046 SUPPLEMENTAL REPORT 1 FILED ON 04/06/2016, AND MDR 2120016-2016-00046 SUPPLEMENTAL REPORT 2 FILED ON 05/12/2016 FOR ADDITIONAL INFORMATION. ON 06/01/2016 ADDITIONAL INFORMATION: SIEMENS IS NOT ABLE TO OBTAIN ADDITIONAL PATIENT MEDICAL HISTORY OR INFORMATION FOR FURTHER INVESTIGATION. BASED ON THE DIGOXIN TEST RESULTS FROM THE RETURNED SAMPLED, AND A REVIEW OF THE PATIENT'S MEDICATIONS, IT HAS BEEN DETERMINED THAT AN INTERFERENT WAS THE CAUSE OF THE ADVIA CENTAUR XP ELEVATED DIGOXIN RESULTS, HOWEVER NOT ATTRIBUTED TO THE COMMON MEDICATIONS THE PATIENT WAS TAKING AT THE TIME OF TESTING. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER INVESTIGATION IS REQUIRED.

    Description of Event or Problem · 1

    A FALSE HIGH ADVIA CENTAUR XP DIGOXIN (DIG) RESULT WAS OBTAINED ON A PATIENT SAMPLE AND CONSIDERED DISCORDANT COMPARED TO A LOWER ALTERNATE TEST METHOD RESULT. DUE TO THE INITIALLY HIGH DIGOXIN RESULT, THE PATIENT WAS TREATED WITH DIGIFAB. THE PATIENT SAMPLE WAS TESTED AT ANOTHER LABORATORY (SISTER SITE) WITH AN ADVIA CENTAUR XP SYSTEM AND THE DIGOXIN RESULT WAS HIGH. THE PATIENT SAMPLE WAS RUN ON AN ALTERNATE DIGOXIN TEST METHOD AND THE RESULT WAS LOW. THE ALTERNATE DIGOXIN TEST METHOD RESULT WAS CONSISTENT WITH THE PATIENT'S CLINICAL HISTORY AND A CORRECTED REPORT WAS ISSUED. THE EMERGENCY ROOM (ER) PHYSICIAN HAS QUESTIONED THE VALIDITY OF ALL THE HIGH ADVIA CENTAUR XP SAMPLE RESULTS. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135698 ADVIA CENTAUR XP DIGOXIN (DIG) ASSAY DIGOXIN IMMUNOASSAY KXT SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 021216

    Patients

    Seq Age Sex Outcome Treatment
    1