HEMOSIL SYNTHASIL
Received Apr 1, 2026 · Event occurred Mar 4, 2026
Report 1217183-2026-00002 · MDR key 24754148
Device
Generic name
Activated Partial Thromboplastin
Manufacturer
Instrumentation Laboratory Co.Catalog number
00020006800
Lot number
N1046401
Product problems
- Device Ingredient or Reagent Problem
- Installation-Related Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
REVIEW OF THE INSTRUMENT SERVICE HISTORY INDICATED THAT THE CUSTOMER REPORTED INCORRECT LOW APTT RESULTS FOR SIX PATIENT SAMPLES, WITH REPEAT TESTING PRODUCING HIGHER VALUES. DURING THE ON-SITE SERVICE VISIT, THE FIELD SERVICE ENGINEER (FSE) REPORTED CUVETTE SHUTTLE MOVEMENT FAILURE AND UPON TROUBLESHOOTING, FOUND CUVETTE WAS UPSIDE DOWN INSIDE THE INSTRUMENT. ALSO, FSE CONFIRMED LOW APTT QUALITY CONTROL (QC) RESULTS. REVIEW OF THE INSTRUMENT ERROR LOGS DID NOT IDENTIFY ANY ERRORS RELATED TO THE REPORTED CONDITION. DIAGNOSTIC EVALUATION REVEALED THAT THE RED LED DIGITAL-TO-ANALOG CONVERTER (DAC) VALUE WAS 215, APPROACHING THE UPPER LIMIT OF THE OPERATING RANGE. THE RED LED WAS REPLACED AND THE DAC VALUES WERE ADJUSTED TO FALL WITHIN SPECIFICATION. FURTHER INSPECTION OF ON-BOARD REAGENTS IDENTIFIED FLOATING CONTAMINANTS IN THE FACTOR DILUENT BOTTLE. THE FSE PERFORMED AIR AND FACTOR DILUENT BLANKING, INSPECTED PROBES AND REAGENT AND SAMPLE FLUIDIC PATHWAYS, AND CONDUCTED FLUIDIC PRECISION AND FLOW RATE TESTING; ALL TESTS MET ACCEPTANCE CRITERIA. SUBSEQUENT QC AND PATIENT SAMPLE TESTS PERFORMED BY THE CUSTOMER YIELDED PASSING RESULTS, INDICATING RESOLUTION OF THE REPORTED ISSUE. NO PATIENT IMPACT REPORTED. BASED ON THIS ASSESSMENT, NO REMEDIAL ACTION IS REQUIRED. THIS INCIDENT WILL BE MONITORED THROUGH TRENDING ANALYSIS.
Description of Event or Problem
ON (B)(6) 2026, SIX PATIENT SAMPLES GENERATED ERRONEOUSLY LOW APTT RESULTS WHEN TESTED WITH HEMOSIL SYNTHASIL LOT N1046401 ON AN ACL TOP 300 CTS (SN (B)(6)). THE SAMPLES WERE RERUN AND GENERATED HIGHER RESULTS, AFTER WHICH CORRECTED PATIENT REPORTS WERE ISSUED. DURING TROUBLESHOOTING FOR CUVETTE SHUTTLE MOVEMENT ERRORS, IT WAS DETERMINED THAT CUVETTES HAD BEEN LOADED UPSIDE DOWN. QUALITY CONTROL AUTO-EXECUTED AND FAILED LOW FOR BOTH LEVELS. SOON AFTER, THE APTT-SS REAGENT GENERATED A "LEVEL LOW" WARNING; THE REAGENT WAS REPLACED AND QC PASSED WITHIN THE EXPECTED RANGE. SERVICE WAS DISPATCHED TO THE SITE. NO PATIENT IMPACT WAS REPORTED.