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

Catalog Number	0020006800
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is an initial report.Investigation is ongoing.A final report will be submitted upon completion of the investigation.Note: this complaint was originally opened on (b)(6) 2025 and was determined to be non-reportable based on our risk assessment.Due to findings received on (b)(6) 2025 during the course of the investigation, the complaint was reassessed and determined to be reportable.Based on these details provided, the awareness date was updated to (b)(6) 2025.Further investigation is ongoing; a final report will be submitted accordingly.
Event or Problem Description
A complaint was submitted on hemosil synthasil, part number 00020006800, lot n0441431.On (b)(6) 2025, the customer observed a discrepancy in measurements for synthasil with a patient sample measured on acl top 750 las - sn (b)(6), in comparison to measurement on acl top 750 cts - sn (b)(6).There was no patient impact and no change to patient therapy based on these results.
Additional Manufacturer Narrative
An in-house trace analysis of the submitted instrument backup was performed.The change in fluid detected height following the sample aspiration for the erroneous aptt test (sample id ((b)(6)) was potentially greater than expected for the volume aspirated, indicating there may have been a mis-aspiration of the sample.However, since there were only 2 aspirations from this sample we were unable to confirm.Based on the risk assessment no remedial action is required.Note: there was no patient impact due to the erroneous results.There was no patient impact.No change to patient therapy based on these results.

• 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: 22540453
• Report Number: 1217183-2025-00036
• Device Sequence Number: 21014360
• Product Code: GFO
• UDI-Device Identifier: 08426950078920
• UDI-Public: (01)08426950078920(11)240501(17)260430(10)N0441431
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 08/29/2025

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): Initial
• Initial Date Received by Manufacturer: 06/18/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/18/2025
• Supplement Report FDA Received Date: 08/29/2025
• 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