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

Catalog Number	00020006800
Medical Device Problem Code	Device Ingredient or Reagent Problem (2910)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2026
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
On (b)(6) 2026, the customer reported erroneously low aptt results (<21.0 seconds), below their established cutoff, for four patient samples when testing with hemosil synthasil, lot n0754328, on an acl top 350 cts (serial number (b)(6).For sample (b)(6), testing was performed at 10:55 and 11:16 on the same day, with both aptt results reported as <21.0 seconds.The user then repeated the test on another analyzer (acl top, serial number (b)(6), which produced an aptt value of 30.2 seconds.A corrected patient report was subsequently issued.A service visit was dispatched to evaluate the instrument.No hardware related issues were identified, and system verification passed.No patient impact reported.
Additional Manufacturer Narrative
Manufacturing and qc records for hemosil synthasil lot n0754328, normal control 1 lot n0834406, and abnormal control 3 lot n0754344 were reviewed.All lots met specifications with no trends or nonconformances identified.Instrument evaluation of acl top 350 cts sn (b)(6) found all checked components operating within specification and no hardware defects.Review of sample and qc data showed low aptt-ss recoveries and failed aptt qc events earlier in the day, with recovery to acceptable qc later.Pt-read qc remained within expected limits.Although the root cause of the erroneous aptt-ss performance cannot be conclusively determined, reagent contamination remains a plausible contributor to the inconsistent qc recovery and low aptt results.To reduce the potential for recurrence, users are advised to insert reagent racks carefully to minimize splashing and associated contamination risk.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.; 526 route 303; orangeburg NY 10962
• Manufacturer Contact: keith kelly ; 180 hartwell road; bedford, MA 01730-2443
• MDR Report Key: 24308474
• Report Number: 1217183-2026-00001
• Device Sequence Number: 21239229
• Product Code: GFO
• UDI-Device Identifier: 08426950078920
• UDI-Public: (01)08426950078920(11)250801(17)270731(10)N0754328
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2026

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 Catalogue Number: 00020006800
• Device Lot Number: N0754328
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/08/2025
• 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