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

Catalog Number	00020006800
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is an initial report.A follow-up report will be submitted upon investigation completion.
Event or Problem Description
Erroneous aptt test results caused by suspected problematic reagent.The operator placed two sets of aptt reagents (the second set was brand new).The initial aptt quality control was normal, with a result of 30.2 seconds (target value 29.0 seconds).When the first set of aptt reagents was exhausted and the second set was switched in, starting from sample number (b)(6), all patient sample aptt results were significantly lower than normal.After noticing the abnormal results, the operator replaced the suspected problematic reagent and retested.Retesting showed large discrepancies in results, confirming reagent issues.No adverse event or patient impact reported.
Additional Manufacturer Narrative
A review of the submitted instrument backup for acl top 700 sn (b)(6) sw 5.4.0 p 16.8.00, dated 8/13/2025, was performed.A review of the sample list on 8/13/2025 from 09:44:31 to 11:58:37 confirms the submitted data containing the list of samples.Review of the 5 samples in question showed that all results were flagged with mt 5600 maintenance overdue or failed.A review of the second derivative curves from the initial results indicates complete clot formation; however, the absence of a baseline suggests the possible use of a contaminated reagent.The repeat result second derivative curves show normal reaction curve presentation.A review of the general log list does not show any instrument errors or warnings that may have contributed to the lower than expected results.A review of the service history for acl top 700 sn 17061251 shows the instrument is up to date on the required preventive maintenance.The root cause of the shortened patient results could not be determined.However, complaint analysis suggests a high likelihood of contamination affecting the assay reagent components.The issue was successfully resolved by replacing the affected reagent.There was no patient impact.Based on this assessment, no remedial action is required.This incident 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 2443
• Manufacturer (Section G): INSTRUMENTATION LABORATORY CO.; 180 hartwell road; bedford 01730 2443
• Manufacturer Contact: anuja khan ; 180 hartwell road; bedford, MA 01730-2443
• MDR Report Key: 22902456
• Report Number: 1217183-2025-00042
• Device Sequence Number: 15656928
• Product Code: GFO
• UDI-Device Identifier: 08426950078920
• UDI-Public: (01)08426950078920(11)240501(17)260430(10)N0441439
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2025

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: 00020006800
• Device Lot Number: N0441439
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 09/11/2025
• 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