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	07/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Instrument backup review of acl top 750 las (b)(6) showed qc results outside insert acceptance ranges, flagged with "mt 5600 maintenance overdue or failed." no instrument errors were logged.Qa retain testing of lot n0844847 performed in-house recovered within acceptance ranges, confirming reagent performance.Lot records and certificates of analysis reviewed for reagent and controls - no abnormalities.Qa retains tested and were within specifications.Analysis suggests contamination of reagent components (aptt-ss and/or aptt-ss cacl2).Unable to determine the cause of the contamination.No remedial action required.
Event or Problem Description
A complaint was received regarding hemosil synthasil (lot n0844847) used on acl top 750 las (b)(6), where aptt results were observed shorter than expected for hemosil normal control assayed (lot n0824873) and hemosil low abnormal control assayed (lot n0532071).Laboratory staff suspected reagent vial contamination.Replacing the reagent restored expected recoveries.Subsequent investigation (7/31/2025) confirmed twelve patient samples tested on (b)(6) 2025 also produced shortened aptt results.Results were corrected after retesting on a separate acl top 750 las analyzer (b)(6).No patient harm occurred.

• Brand Name: HEMOSIL SYNTHASIL
• Common Device Name: ACTIVATED PARTIAL THROMBOPLASTIN
• Manufacturer (Section D): INSTRUMENTATION LABORATORY CO.; 180 hartwell road; bedford MA 01730 2443
• Manufacturer (Section G): INSTRUMENTATION LABORATORY CO.; 180 hartwell road; bedford MA 01730 2443
• Manufacturer Contact: anuja khan ; 180 hartwell road; bedford, MA 01730-2443
• MDR Report Key: 22852973
• Report Number: 1217183-2025-00041
• Device Sequence Number: 15558953
• Product Code: GFO
• UDI-Device Identifier: 08426950078920
• UDI-Public: (01)08426950078920(11)240901(17)260831(10)N0844847
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 08/20/2025

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
• Device Expiration Date: 08/31/2026
• Device Catalogue Number: 0020006800
• Device Lot Number: N0844847
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2025
• Initial Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2024
• 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