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

Catalog Number	00020006800
Medical Device Problem Codes	Device Ingredient or Reagent Problem (2910); Installation-Related Problem (2965)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the instrument service history indicated that the customer reported incorrect low aptt results for six patient samples, with repeat testing producing higher values.During the on-site service visit, the field service engineer (fse) reported cuvette shuttle movement failure and upon troubleshooting, found cuvette was upside down inside the instrument.Also, fse confirmed low aptt quality control (qc) results.Review of the instrument error logs did not identify any errors related to the reported condition.Diagnostic evaluation revealed that the red led digital-to-analog converter (dac) value was 215, approaching the upper limit of the operating range.The red led was replaced and the dac values were adjusted to fall within specification.Further inspection of on-board reagents identified floating contaminants in the factor diluent bottle.The fse performed air and factor diluent blanking, inspected probes and reagent and sample fluidic pathways, and conducted fluidic precision and flow rate testing; all tests met acceptance criteria.Subsequent qc and patient sample tests performed by the customer yielded passing results, indicating resolution of the reported issue.No patient impact reported.Based on this assessment, no remedial action is required.This incident will be monitored through trending analysis.
Event or Problem Description
On (b)(6) 2026, six patient samples generated erroneously low aptt results when tested with hemosil synthasil lot n1046401 on an acl top 300 cts (sn (b)(6)).The samples were rerun and generated higher results, after which corrected patient reports were issued.During troubleshooting for cuvette shuttle movement errors, it was determined that cuvettes had been loaded upside down.Quality control auto-executed and failed low for both levels.Soon after, the aptt-ss reagent generated a "level low" warning; the reagent was replaced and qc passed within the expected range.Service was dispatched to the site.No patient impact was reported.

• 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: 24754148
• Report Number: 1217183-2026-00002
• Device Sequence Number: 9230287
• Product Code: GFO
• UDI-Device Identifier: 08426950078920
• UDI-Public: (01)08426950078920(11)241101(17)261031(10)N1046401
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 04/01/2026

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: N1046401
• 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: 03/04/2026
• Initial Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2024
• 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