ATELLICA IM PROLACTIN (PRL)

Additional Manufacturer Narrative

MDR 1219913-2025-00218 WAS INITIALLY FILED ON 11-DEC-2025. ADDITIONAL INFORMATION (16-DEC-2025): SIEMENS HEALTHCARE DIAGNOSTICS HAS CONCLUDED THE INVESTIGATION OF THE EVENT. A CUSTOMER FROM OUTSIDE THE UNITED STATES (OUS) REPORTED OBSERVATION OF A DEPRESSED PROLACTIN ATELLICA IM RESULT, WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING ON AN ALTERNATE METHOD. SIEMENS EVALUATED THE INSTRUMENT DATA AND THE INFORMATION PROVIDED BY THE CUSTOMER. THE ORIGINAL PATIENT SPECIMEN COULD NOT BE RETESTED USING HETEROPHILIC BLOCKING TUBES (HBT/NABT) DUE TO SAMPLE DEPLETION. POTENTIAL REAGENT-RELATED ISSUES WERE RULED OUT BASED ON QUALITY CONTROL (QC) DATA, WHICH RECOVERED WITHIN ACCEPTABLE RANGES, AND NO ANOMALIES WERE REPORTED FOR OTHER PATIENT SAMPLES. THE PROLACTIN INSTRUCTION FOR USE (IFU), DOCUMENT NUMBER 11200387_EN REV. 06 (2024-05), DOES NOT INCLUDE SPECIFICATIONS FOR COMPARATIVE ANALYSIS WITH COMPETITOR PLATFORMS. SIEMENS HAS NOT ESTABLISHED OR VALIDATED A POLYETHYLENE GLYCOL (PEG) PRECIPITATION PROTOCOL FOR MACROPROLACTIN ASSESSMENT. THE SAMPLE EXHIBITED ERRATIC BEHAVIOR, AND HETEROPHILIC INTERFERENCE TESTING COULD NOT BE PERFORMED DUE TO INSUFFICIENT SAMPLE VOLUME. BASED ON THE AVAILABLE INFORMATION, THE CAUSE OF THE DISCORDANT RESULT CANNOT BE DETERMINED. A PRODUCT PROBLEM HAS NOT BEEN IDENTIFIED. THE CUSTOMER IS OPERATIONAL, AND THE REPORTED ISSUE WAS RESOLVED BY ROUTINE TROUBLESHOOTING. NOTE: IN SECTION H6, THE CODES FOR INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS HAVE BEEN UPDATED. IN SECTION A1, SAMPLE IDENTIFIER HAS BEEN UPDATED. IN SECTION D8, WAS THE INSTRUMENT SERVICED BY A 3RD PARTY QUESTION HAS BEEN UPDATED AS NO.

Additional Manufacturer Narrative

AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED THE SIEMENS REMOTE SERVICES CENTER (RSC) AND REPORTED AN OBSERVATION OF A DEPRESSED PROLACTIN ATELLICA IM RESULT, WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING ON AN ALTERNATE METHOD. THE ASSAY'S INSTRUCTION FOR USE (IFU) STATES UNDER INTERPRETATION OF RESULTS SECTION: "RESULTS OF THIS ASSAY SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH THE PATIENT¿S MEDICAL HISTORY, CLINICAL PRESENTATION, AND OTHER FINDINGS." SIEMENS IS EVALUATING THE EVENT.

Description of Event or Problem

THE CUSTOMER REPORTS OBSERVATION OF AN ERRONEOUSLY DEPRESSED PROLACTIN (PRL) RESULT ON A PATIENT SAMPLE ON THE ATELLICA IM 1600 ANALYZER, WHEN USING REAGENT LOT 219. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S) AND QUESTIONED. FOR TROUBLESHOOTING PURPOSES, THE SAMPLE WAS REPEATED TWICE ON AN ALTERNATE ATELLICA IM 1600 ANALYZER AND OBTAINED A LOWER AND HIGHER RESULT. THE SAME SAMPLE WAS REPEATED USING AN ALTERNATE TEST METHOD AND OBTAINED A HIGHER RESULT. THIS REPEAT RESULT WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.