BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR CP ENHANCED ESTRADIOL (EE2) ASSAY

    MDR report key: 6508279 · Received April 20, 2017

    Report

    Report Number
    1219913-2017-00084
    Event Type
    Malfunction
    Date Received
    April 20, 2017
    Date of Event
    March 28, 2017
    Report Date
    July 6, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    CHP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS FILED MDR 1219913-2017-00084 REGARDING AN OBSERVATION OF AN ADVIA CENTAUR CP ENHANCED ESTRADIOL (EE2) RESULT THAT WAS HIGHER UPON REPEAT TESTING WITH A DIFFERENT READYPACK OF REAGENTS. ON APRIL 28, 2017 - ADDITIONAL INFORMATION: THE CUSTOMER STATES THAT ISSUE IS ONGOING. THE CUSTOMER WILL SEE LOWER RECOVERY AS THE READYPACK AGES AND VOLUME DIPS BELOW 25 TESTS IN THE READYPACK. HE PLACES NEW READYPACK ON BOARD AND QC WILL GO BACK UP. THE CUSTOMER REPORTED THAT THEY NOTED THIS WITH REAGENT LOT 036 AS WELL AS REAGENT LOT 035. THE CUSTOMER PROVIDED THE FOLLOWING DATA: (B)(6). SIEMENS CONTINUES TO INVESTIGATE THE ISSUE WITH THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    SIEMENS FILED MDR 1219913-2017-00084 REGARDING AN OBSERVATION OF AN ADVIA CENTAUR CP ENHANCED ESTRADIOL (EE2) RESULT THAT WAS HIGHER UPON REPEAT TESTING WITH A DIFFERENT READYPACK OF REAGENTS. MDR 1219913-2017-00084 SUPPLEMENTAL REPORT 1 WAS FILED ON APRIL 28, 2017 WITH ADDITIONAL DATA. JUNE 07, 2017 - ADDITIONAL INFORMATION: THE CUSTOMER PERFORMED A PRECISION STUDY USING ADVIA CENTAUR CP ENHANCED ESTRADIOL REAGENT LOT 036 AND MASTER CURVE MATERIAL. THREE REPLICATES OF THE MCMS WERE RUN WITH A FRESH PACK AND DUPLICATES WERE RESULTED WITH AN EE2 A PACK THAT ONLY HAD 35 TESTS REMAINING. MCM 1: 5 REPLICATES MEAN ALL WERE <11 CV 6.54% MCM 2: 5 REPLICATES, MEAN 66 , CV 4.34%. MCM 3: 5 REPLICATES, MEAN 202, CV 1.67%. MCM 4: 5 REPLICATES, MEAN 468, CV 1.59%. MCM 5: 5 REPLICATES, MEAN 1907, CV 3.45%. MCM 6: 5 REPLICATES, MEAN >3000, CV 1.94%. MCM ON BOARD X5 DILUTION: 5 REPS, MEAN 2179 , CV 3.06%. MCM RANGES 44935: LEVEL 1 <32.1 LEVEL 2 48.8 - 81.3. LEVEL 3 129 - 215. LEVEL 4 354 - 590. LEVEL 5 1222 - 2036. LEVEL 6 > 2262. THE FIVE MCM REPLICATES RESULTS ACCEPTABLE AND INDISTINGUISHABLE. PRECISION IS ACCEPTABLE. SINCE THE COMPLAINT WAS RECEIVED, SERVICE HAS BEEN ON-SITE. SERVICE REPLACED REAGENT AND SAMPLE PROBES AND DILUTORS. FOLLOWING SERVICE, ESTRADIOL PRECISION WAS CHECKED USING MASTER CURVE MATERIAL. RESULTS OBTAINED ON A FRESH VS. LOW VOLUME PACK ARE CONSISTENT. PERFORMANCE OF THE ESTRADIOL ASSAY AT THIS ACCOUNT IS ACCEPTABLE FOLLOWING SERVICE. A PRODUCT ISSUE WAS NOT IDENTIFIED. THE CUSTOMER REPORTED THAT NO DOCTORS QUESTIONED ANY PATIENT RESULTS AND THERE WERE NO CORRECTED REPORTS OR A DELAY IN REPORTING RESULTS. NO FURTHER INVESTIGATION REQUIRED FOR THIS INCIDENT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CUSTOMER OBSERVED AN ADVIA CENTAUR CP ENHANCED ESTRADIOL (EE2) RESULT THAT WAS HIGHER UPON REPEAT TESTING. THE PATIENT RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE NON-REPRODUCIBLE ADVIA CENTAUR CP EE2 RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290585 ADVIA CENTAUR CP ENHANCED ESTRADIOL (EE2) ASSAY ENHANCED ESTRADIOL IMMUNOASSAY, CHP SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 73438035

    Patients

    Seq Age Sex Outcome Treatment
    1