MAUDE Adverse Event Report: INSTRUMENTATION LABORATORY CO. HEMOSIL SYNTHASIL; ACTIVATED PARTIAL THROMBOPLASTIN

Catalog Number	0020006800
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A complaint was submitted on hemosil synthasil, part number 00020006800, lot n0441431.The customer observed discrepant aptt results measured on acl top 750 las (sn (b)(6)).A corrected report was generated.
Additional Manufacturer Narrative
A complaint was submitted on hemosil synthasil pn 00020006800 lot n0441431 used on the acl top 750 las sn (b)(6).There was no patient impact.Sample result detail reports were submitted for the investigation, which verified the results in question.The customer states that they reported an incorrect result and had to generate a corrected report for 4 aptt-ss samples.The customer ran the quality control (qc) for test code aptt which failed for both levels.Upon troubleshooting the issue and checking the error log, a warning for low hemosil cleaning solution was found at 21:23.A field service engineer (fse) was dispatched to check on the analyzer.The service report also shows the fse performed instrument verification and performed the "clean all probes" function, secured precision tubing, checked the 3-way valve and coordinated alignment for all instrument arms.The customer replaced the hemosil clean solution, made up fresh qc and reagents, and performed the enhanced clean for all probes prior to rerunning quality control.The customer ran qc with passing results.A review of the certificate of analysis (coa) for hemosil synthasil pn 0020006800 lot n0441431 was performed.The reagent met all specifications; no abnormalities were found.The acl top family 50 series operator's manual states that "for users performing more than 50 thrombin-based or factor xa based tests (antithrombin, clauss, fibrinogen, thrombin time, or heparin assays) per day, it is strongly recommended that the enhanced clean be performed on all probes once per shift.For users running fewer than 50 thrombin-based or factor xa-based tests per day, the enhanced clean should be performed once per day." while the root cause of the reported unacceptable performance for appt cannot be determined, there are many variables that have the potential to influence the result recoveries.This information has been forwarded to the werfen risk assessment process and will be monitored through trending analysis.

• Brand Name: HEMOSIL SYNTHASIL
• Common Device Name: ACTIVATED PARTIAL THROMBOPLASTIN
• Manufacturer (Section D): INSTRUMENTATION LABORATORY CO.; 180 hartwell road; bedford MA 01730
• Manufacturer (Section G): INSTRUMENTATION LABORATORY CO.; 180 hartwell road; bedford MA 01730
• Manufacturer Contact: anuja khan ; 180 hartwell road; bedford, MA 01730
• MDR Report Key: 23489860
• Report Number: 1217183-2025-00049
• Device Sequence Number: 18310831
• Product Code: GFO
• UDI-Device Identifier: 08426950078920
• UDI-Public: (01)08426950078920(11)240501(17)260430(10)N0441431
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K060688
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/06/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2026
• Device Catalogue Number: 0020006800
• Device Lot Number: N0441431
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2025
• Initial Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown