ATELLICA IM BR 27.29 (BR)

Description of Event or Problem

THE CUSTOMER REPORTS OBSERVATION OF A DEPRESSED ELEVATED ATELLICA IM BR 27.29 (BR) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING WHEN USING BR LOT 272. A LOWER-THAN-EXPECTED ATELLICA IM BR RESULT WAS OBTAINED FOR THE PATIENT IN QUESTION. AS THIS RESULT WAS INCONSISTENT WITH PATIENT HISTORY, THE TEST WAS REPEATED USING ANOTHER ATELLICA IM INSTRUMENT. THE REPEAT-TEST RESULT WAS HIGHER, AND CONSISTENT WITH PAST HISTORY. THERE ARE NO ALLEGATIONS OF ANY ADVERSE PATIENT CONSEQUENCES DUE TO THE OBSERVED RESULT DISCORDANCE.

Additional Manufacturer Narrative

A CUSTOMER FROM OUTSIDE THE UNITED STATES REPORTED OBSERVATION OF A DEPRESSED ATELLICA IM BR 27.29 (BR) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING. NO ISSUES WERE IDENTIFIED WITH ASSAY QUALITY CONTROL (QC) RESULTS. SIEMENS IS INVESTIGATING.

Additional Manufacturer Narrative

A CUSTOMER FROM OUTSIDE THE UNITED STATES REPORTED OBSERVATION OF A DEPRESSED ELEVATED ATELLICA IM BR 27.29 (BR) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING. MDR 1219913-2025-00043 WAS INITIALLY SUBMITTED ON 26-FEB-2025, WITH A FOLLOW-UP (CORRECTION) ON 28-FEB-2025. UPDATE, 14-MAR-2025: SIEMENS HAS CONCLUDED THE INVESTIGATION. NO ISSUES WERE IDENTIFIED WITH ATELLICA IM BR ASSAY CALIBRATION OR QUALITY CONTROL (QC) RESULTS. NO ISSUES WERE REPORTED FOR ANY OTHER PATIENT SAMPLES. RETURN OF THE PATIENT SAMPLE IS NOT WARRANTED AS THE DISCORDANT RESULT WAS NOT REPRODUCIBLE. REVIEW OF INSTRUMENT DATA SHOWED NO EVIDENCE OF ANY ASPIRATION OR DISPENSE ISSUES AFFECTING THE DELIVERY OF THE SAMPLE OR REAGENTS. THE CUSTOMER STORED THE SAMPLE FROZEN, AND ON (B)(6) 2025 IT WAS THAWED AND RE-TESTED IN DUPLICATE ON THE ORIGINAL ANALYZER AS WELL AS ON THE INSTRUMENT USED FOR REPEAT TESTING. ALL REPLICATES AGREED WITH THE INITIAL RE-TEST, WITH GOOD AGREEMENT BETWEEN SYSTEMS; NO DISCORDANCE WAS OBSERVED. BASED ON THE AVAILABLE INFORMATION, A SPECIFIC CAUSE FOR THE FALSELY ELEVATED RESULTS OBSERVED FOR THE FIRST SAMPLE COULD NOT BE IDENTIFIED. THE CUSTOMER IS OPERATIONAL, AND THE REPORTED ISSUE WAS RESOLVED BY REPEATING THE TEST. NO SYSTEMIC PRODUCT PROBLEMS WERE IDENTIFIED. NOTE: IN SECTION H6, THE CODES FOR INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS HAVE BEEN UPDATED.

Additional Manufacturer Narrative

SECTION B5: TEXT CORRECTED TO READ "THE CUSTOMER REPORTS OBSERVATION OF A DEPRESSED ATELLICA IM BR 27.29 (BR) RESULT...", WHERE IT HAD EARLIER SAID "THE CUSTOMER REPORTS OBSERVATION OF A DEPRESSED ELEVATED ATELLICA IM BR 27.29 (BR) RESULT..."

Description of Event or Problem

THE CUSTOMER REPORTS OBSERVATION OF A DEPRESSED ELEVATED ATELLICA IM BR 27.29 (BR) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING WHEN USING BR LOT 272. A LOWER-THAN-EXPECTED ATELLICA IM BR RESULT WAS OBTAINED FOR THE PATIENT IN QUESTION. AS THIS RESULT WAS INCONSISTENT WITH PATIENT HISTORY, THE TEST WAS REPEATED USING ANOTHER ATELLICA IM INSTRUMENT. THE REPEAT-TEST RESULT WAS HIGHER, AND CONSISTENT WITH PAST HISTORY. THERE ARE NO ALLEGATIONS OF ANY ADVERSE PATIENT CONSEQUENCES DUE TO THE OBSERVED RESULT DISCORDANCE.

Additional Manufacturer Narrative

CORRECTION: FOLLOW-UP REPORT SUBMITTED ON 14-MAR-2025 CONTAINED ERRONEOUS REFERENCES TO "FALSELY ELEVATED" RESULTS. CORRECTED TEXT FOR H10 BELOW: A CUSTOMER FROM OUTSIDE THE UNITED STATES REPORTED OBSERVATION OF A DEPRESSED ATELLICA IM BR 27.29 (BR) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING. MDR 1219913-2025-00043 WAS INITIALLY SUBMITTED ON 26-FEB-2025, WITH A FOLLOW-UP (CORRECTION) ON 28-FEB-2025. UPDATE, 14-MAR-2025: SIEMENS HAS CONCLUDED THE INVESTIGATION. NO ISSUES WERE IDENTIFIED WITH ATELLICA IM BR ASSAY CALIBRATION OR QUALITY CONTROL (QC) RESULTS. NO ISSUES WERE REPORTED FOR ANY OTHER PATIENT SAMPLES. RETURN OF THE PATIENT SAMPLE IS NOT WARRANTED AS THE DISCORDANT RESULT WAS NOT REPRODUCIBLE. REVIEW OF INSTRUMENT DATA SHOWED NO EVIDENCE OF ANY ASPIRATION OR DISPENSE ISSUES AFFECTING THE DELIVERY OF THE SAMPLE OR REAGENTS. THE CUSTOMER STORED THE SAMPLE FROZEN, AND ON 05-MAR-2025 IT WAS THAWED AND RE-TESTED IN DUPLICATE ON THE ORIGINAL ANALYZER AS WELL AS ON THE INSTRUMENT USED FOR REPEAT TESTING. ALL REPLICATES AGREED WITH THE INITIAL RE-TEST, WITH GOOD AGREEMENT BETWEEN SYSTEMS; NO DISCORDANCE WAS OBSERVED. BASED ON THE AVAILABLE INFORMATION, A SPECIFIC CAUSE FOR THE FALSELY DEPRESSED RESULT OBSERVED FOR THE INITIAL TEST COULD NOT BE IDENTIFIED. THE CUSTOMER IS OPERATIONAL, AND THE REPORTED ISSUE WAS RESOLVED BY REPEATING THE TEST. NO SYSTEMIC PRODUCT PROBLEMS WERE IDENTIFIED.