STA SATELLITE PACK

Additional Manufacturer Narrative

(B)(6) 2025, OUR FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND FOUND PARTIAL BLOCKAGE IN THE ARM SAMPLE TUBING. THE FSE REPLACED THE ARM ASSEMBLY AND PDR ASSEMBLY. INSTRUMENT DATA FILES WERE COLLECTED AND SENT TO STAGO'S TECHNICAL SUPPORT TEAM IN FRANCE FOR ANALYSIS. THE ANALYSIS OF INSTRUMENT FILES SHOWED THE KINETIC CURVE OF THE ERRONEOUS RESULT WAS VERY LOW, POSSIBLY DUE TO NOT ENOUGH LIQUID IN THE REACTION MEDIUM AND COMPATIBLE WITH FSE REPAIR. MOREOVER, THE REPEATED D-DIMER RESULT 6.68G/ML WAS PRODUCED ON (B)(6) 2025 AT 11:15 AS D-DIMER ABNORMAL QUALITY CONTROL PRODUCED ON (B)(6) 2025 AT 08:16 AND 08:25 WERE OUT OF RANGES. ON PREVIOUS DAYS, THE D-DIMER QC'S ALSO SHOWED SPORADIC LOW AND OUT OF RANGE RESULTS, THOUGH PATIENT RESULTS WERE UNAFFECTED. THUS, THE SYSTEM HAS ALERTED THE USER OF AN ISSUE WITH THE ANALYZER THROUGH WITH THE QC OUT OF RANGE. INDEED, ACCORDING TO THE REFERENCE MANUAL OF THE INSTRUMENT, REF. (B)(4) CHAP. 9 QUALITY CONTROL, THE SYSTEM FUNCTIONED AS EXPECTED. STAGO CONCLUDES ITS INVESTIGATION ON THIS MATTER AND PLANS NO FURTHER ACTION. SEE MANUFACTURER REPORT NUMBER: 8043723-2025-00002. STAGO REFERENCE FILE: (B)(4) THIS REPORT IS SUBMITTED BY THE IMPORTER.

Description of Event or Problem

ON (B)(6) 2025, CUSTOMER CALLED THE HOTLINE STATING AN ERRONEOUS D-DIMER TEST RESULT WAS INITIALLY REPORTED OUT AS NEGATIVE LOW BUT LATER RETESTED POSITIVE. (B)(6) 2025, THE LAB RETURNED A COMPLETED CUSTOMER QUESTIONNAIRE TO OUR HOTLINE REGARDING SID (B)(6). AS PER THE QUESTIONNAIRE, AN ERRONEOUS RESULT WAS PRODUCED ON (B)(6) 2025 AT 03:19 (ORIGINAL D-DIMER RESULT 0.37G/ML) AND REPORTED TO THE PHYSICIAN. THE PATIENT WAS DISCHARGED AS THE PHYSICIAN STATED THAT THEY DID NOT SEE ANY OTHER CLINICAL PRESENTATION OF DEEP VEINOUS THROMBOSIS/PULMONARY EMBOLISM. COMPUTED TOMOGRAPHY SCAN (CT SCAN) WAS NOT PERFORMED AT THAT TIME. AT 8AM ON (B)(6) 2025, D-DIMER ABNORMAL QC WAS OUT OF RANGE (0.41G/ML RERAN 0.39G/ML FOR STAGO RANGES: [1.60 - 2.40]). THEREFORE, CUSTOMER REPEATED THE PATIENT RESULT TO 6.68 G/ML, RELEASED AT 11:15, REPORTED TO PHYSICIAN AT 16:16. ACCORDING TO THE CUSTOMER QUESTIONNAIRE, NO DEATH OR SERIOUS DETERIORATION OF THE PATIENT'S STATE OF HEALTH WAS INDICATED AND NO PRE-EXISTING PATIENT CONDITIONS IN RELATION WITH THE DETERIORATION OF THE STATE OF HEALTH WERE INDICATED. (B)(6) 2025, OUR HOTLINE RECEIVED AN UPDATED CUSTOMER QUESTIONNAIRE REGARDING SID (B)(6) AND REPEATED D-DIMER RESULTS. UPDATED FROM (B)(6) 2025: THE "PATIENT HAD REPEAT TESTING WITH D-DIMER OF 5.83G/ML. CTA PERFORMED WITH CONCERN OF SUBSEGMENTAL PE. PATIENT PLACED ON MEDICATION."