HEMOSIL SYNTHASIL

Additional Manufacturer Narrative

A REVIEW OF THE DEVICE HISTORY RECORD (DHR) AND CERTIFICATE OF ANALYSIS (COA) FOR HEMOSIL SYNTHASIL LOT N1046401 CONFIRMED THE LOT MET ALL MANUFACTURING AND QUALITY ASSURANCE SPECIFICATIONS, WITH NO ABNORMALITIES IDENTIFIED. INVESTIGATION INCLUDED EVALUATION OF CUSTOMER-PROVIDED QC AND PATIENT DATA FOR APTT-SS. FOR NORMAL CONTROL 1 (LOT N0259871), THE INTERVAL MEAN WAS 29.8 SECONDS (APRIL 17-22, 2026). ON APRIL 21, 2026, ONE RESULT (19.7 SECONDS) WAS BELOW THE ACCEPTABLE RANGE, WHILE ALL OTHER VALUES WERE WITHIN LIMITS. FOR ABNORMAL CONTROL 3 (LOT N0159179), THE INTERVAL MEAN WAS 56.8 SECONDS; TWO RESULTS ON THE EVENT DATE (31.6 AND 32.2 SECONDS) WERE BELOW THE ACCEPTABLE RANGE. REVIEW OF PATIENT TESTING (SAMPLE ID (B)(6) SHOWED TWO APTT RESULTS ON APRIL 21, 2026: 30.3 SECONDS AND 53.7 SECONDS. BOTH RESULTS WERE FLAGGED WITH INSTRUMENT MAINTENANCE WARNINGS (MT 5600). SERVICE HISTORY REVIEW IDENTIFIED THAT THE CUSTOMER REPORTED CONDENSATION AND LIQUID PRESENCE IN THE REAGENT AREA ON APRIL 22, 2026. THE PATIENT-RELATED ISSUE WAS REPORTED ALONG WITH OUT-OF-RANGE QC RESULTS AND SUSPECTED REAGENT CONTAMINATION. THE ROOT CAUSE OF THE REAGENT CONTAMINATION COULD NOT BE CONCLUSIVELY DETERMINED. WHILE CONDENSATION AND FLUID EXPOSURE IN THE REAGENT AREA MAY HAVE CONTRIBUTED, THE SOURCE OF THIS CONDITION WAS NOT IDENTIFIED. IMPROPER HANDLING OR ENVIRONMENTAL CONDITIONS CANNOT BE RULED OUT. AS A PRECAUTION, USERS ARE ADVISED TO INSERT REAGENT RACKS SLOWLY AND CAREFULLY TO MINIMIZE THE RISK OF SPLASHING OR CONTAMINATION. ALSO, ALL REQUIRED MAINTENANCE SHOULD BE PERFORMED BEFORE PROCEEDING WITH ANY TESTING ON THE INSTRUMENT. NO EVIDENCE SUGGESTS A MANUFACTURING, DESIGN, OR LABELING DEFECT. PATIENT IMPACT IS UNKNOWN. BASED ON THIS ASSESSMENT, NO FURTHER REMEDIAL ACTIONS ARE REQUIRED. THIS INCIDENT WILL BE MONITORED THROUGH TRENDING ANALYSIS.

Description of Event or Problem

ON 21 APRIL 2026, THE CUSTOMER REPORTED ERRONEOUS APTT RESULT GENERATED USING HEMOSIL SYNTHASIL LOT N1046401 (PN00020006800) ON ACL TOP 550 CTS SN (B)(6) WERE REPORTED ON THE PATIENT CHART. THE USER OBSERVED CONDENSATION AND LIQUID PRESENCE WITHIN THE INSTRUMENT AND SUBSEQUENTLY NOTED THAT THE REAGENTS WERE CONTAMINATED. AFTER THE INITIAL PATIENT RESULT WAS QUESTIONED, QUALITY CONTROL TESTING WAS PERFORMED. CONTROL RESULTS WERE OUT OF RANGE, WITH BOTH NORMAL AND ABNORMAL CONTROLS RUNNING SIGNIFICANTLY LOWER THAN EXPECTED. THE CUSTOMER REPLACED THE APTT REAGENTS AND REPEATED TESTING. FOLLOWING REPLACEMENT, CONTROL VALUES RETURNED TO WITHIN ESTABLISHED ACCEPTABLE RANGES: NORMAL CONTROL: INITIAL RESULT 19.7 SECONDS; POST-REPLACEMENT RESULT 30.5 SECONDS (WITHIN EXPECTED RANGE). ABNORMAL CONTROL: INITIAL RESULT 31.6 SECONDS; POST-REPLACEMENT RESULT 58.6 SECONDS. THE PATIENT SAMPLE WAS ALSO RETESTED: INITIAL RESULT: 30.3 SECONDS. POST-REAGENT REPLACEMENT RESULT: 53.7 SECONDS (CONSISTENT WITH EXPECTED VALUES). THE INITIAL INACCURATE APTT RESULT LED TO CLINICAL INTERVENTION, AND THE PATIENT RECEIVED HEPARIN THERAPY BASED ON THE ERRONEOUS RESULT.