ADVIA CHEMISTRY URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP)

Description of Event or Problem

THE CUSTOMER OBSERVED A FALSELY DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) RESULT ON A PATIENT SAMPLE ON ADVIA CHEMISTRY XPT. THE INITIAL ERRONEOUS RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON THE INITIAL ADVIA CHEMISTRY XPT INSTRUMENT AND OBTAINED THE RESULT SAME AS THE INITIAL RESULT. THE CUSTOMER REPEATED THE SAMPLE ON AN ALTERNATE METHOD FOR ALBUMIN. THE REPEAT RESULT WAS HIGHER THAN THE INITIAL RESULT. THE REPEAT RESULT WAS CONSIDERED AS CORRECT BY THE PHYSICIAN(S) AS URINE ROUTINE TEST FOR THIS SAMPLE WAS POSITIVE FOR URINE PROTEIN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO FALSELY DEPRESSED URINE PROTEIN RESULTS.

Additional Manufacturer Narrative

AN OUTSIDE THE UNITED STATES CUSTOMER OBSERVED A FALSELY DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) RESULT ON A PATIENT SAMPLE ON ADVIA CHEMISTRY XPT. THE INITIAL ERRONEOUS RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON THE INITIAL ADVIA CHEMISTRY XPT INSTRUMENT AND OBTAINED THE RESULT SAME AS THE INITIAL RESULT. THE CUSTOMER REPEATED THE SAMPLE ON AN ALTERNATE METHOD FOR ALBUMIN. THE REPEAT RESULT WAS HIGHER THAN THE INITIAL RESULT. THE REPEAT RESULT WAS CONSIDERED AS CORRECT BY THE PHYSICIAN(S) AS URINE ROUTINE TEST FOR THIS SAMPLE WAS POSITIVE FOR URINE PROTEIN. THE INTERPRETATION OF RESULTS SECTION OF THE ADVIA CHEMISTRY UCFP INSTRUCTIONS FOR USE (IFU) STATES: "RESULTS OF THIS ASSAY SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH THE PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION, AND OTHER FINDINGS." SIEMENS HEALTHCARE DIAGNOSTICS IS INVESTIGATING.

Additional Manufacturer Narrative

SIEMENS FILED THE INITIAL MDR 2432235-2023-00199 ON JUN 30, 2023. ADDITIONAL INFORMATION OCT 13, 2023: AN OUTSIDE THE UNITED STATES CUSTOMER OBSERVED A FALSELY DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) RESULT ON A PATIENT SAMPLE ON ADVIA CHEMISTRY XPT. THE INITIAL ERRONEOUS RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON THE INITIAL ADVIA CHEMISTRY XPT INSTRUMENT AND OBTAINED THE RESULT SAME AS THE INITIAL RESULT. THE CUSTOMER REPEATED THE SAMPLE ON AN ALTERNATE METHOD FOR ALBUMIN. THE REPEAT RESULT WAS HIGHER THAN THE INITIAL RESULT. THE REPEAT RESULT WAS CONSIDERED AS CORRECT BY THE PHYSICIAN(S) AS URINE ROUTINE TEST FOR THIS SAMPLE WAS POSITIVE FOR URINE PROTEIN. SIEMENS HAS REVIEWED THE LIMITED INFORMATION AVAILABLE ON THIS ISSUE. THE ISSUE REPORTED WAS THAT THE ADVIA CHEMISTRY URINARY CEREBROSPINAL FLUID PROTEIN (UCFP) ASSAY RECOVERED A REPEATABLE UCFP RESULTS OF < 60 MG/L WHILE THE SAMPLE WAS PROCESSED ON AN ALTERNATE METHOD FOR URINE ALBUMIN (ALBU). ALBU RESULT WAS 85.3 MG/L. THE SAMPLE ALSO WAS POSITIVE USING A URINE DIPSTICK PROTEIN ASSAY. NO ANALYZER DATA WAS ABLE TO BE PROVIDED FOR SIEMENS TO REVIEW THE REACTION CURVES TO VERIFY NO ISSUE WITH THE REAGENT OR ANALYZER PERFORMANCE. THE SAMPLE WAS NOT AVAILABLE FOR RETURN AND THE CUSTOMER DECLINED TO GIVE ANY MEDICATION HISTORY OR PATIENT DIAGNOSIS. NO CORRELATION STUDIES OR CLAIMS BETWEEN ATELLICA CH UCFP ASSAY AND THE ALTERNATE METHOD ALBU ASSAYS HAVE BEEN PERFORMED AND THE URINE DIPSTICK TESTS ARE SCREENING SEMI-QUANTITATIVE ASSAYS THAT ARE NOT CORRELATED WITH ANY AUTOMATED PROTEIN ASSAY. AN INTERNAL SIEMENS STUDY NOT RELATED TO THIS ISSUE, WAS PERFORMED USING THE SAME METHODOLOGIES TO TEST 30 SAMPLES. THIS STUDY DID NOT SHOW LOW RECOVERY ON A PATIENT SAMPLE AS WAS REPORTED BY THE CUSTOMER ON THIS SINGLE PATIENT. DUE TO THE LACK OF INFORMATION, SIEMENS CANNOT DETERMINE A PROBABLE CAUSE. IN SECTION H6, THE INVESTIGATION FINDING, AND INVESTIGATION CONCLUSION CODES WERE UPDATED.