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	04/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Instrument backup files and sample result reports were submitted and reviewed as part of the investigation.Review of the certificates of analysis for hemosil synthasil lot n0350874 and hemosil readiplastin (20 ml) lot n1248407 confirmed that both reagents met all specifications at the time of product release, with no anomalies identified.The submitted instrument backup for acl top 500 cts, serial number (b)(6) software version 5.2.0 p 16.8.03, dated 07apr2026, was reviewed.The review confirmed that werfen-locked tests (aptt-ss and pt-read) and werfen-locked material definitions (aptt-ss, aptt-ss cacl2, and pt readiplastin) were in place.Review of the submitted sample result reports demonstrated several low aptt-ss and pt-read results generated on (b)(6) 2026.When these samples were repeated on a second acl top instrument (serial number (b)(6), higher results were obtained.Evaluation of the associated clot curves showed typical s-shaped curves with expected baseline, acceleration, and plateau phases; no curve abnormalities were observed.Quality control (qc) statistics were reviewed for normal control 1 (lot n0259871) and abnormal control 3 (lot n1248410), which were tested for aptt-ss and pt-read prior to patient sample testing on (b)(6) 2026.All qc results fell within package insert acceptance ranges except for one abnormal control 3 pt-read result, which was low.Upon repeat testing, the control result recovered within the acceptance range.A review of the service history indicated a customer service call on 07apr2026 reporting erroneous aptt and pt-read results, prompting instrument validation.During verification, dried blood residue was observed on the cts hold-down and was subsequently cleaned.The cts rinse pump was verified to be functioning properly, and fluidic precision tests were successfully performed on both probes.The acl top family 50 series operator's manual, chapter 12 - system, states that as part of good laboratory practice, operators are responsible for ensuring the system is kept clean through visual inspection and maintenance as needed.The manual also provides detailed instructions for cts foot cleaning, including manual cleaning using a lint-free swab and deionized water.Although a definitive root cause could not be established, the discrepant aptt-ss and pt-read results were most likely associated with the presence of dried blood buildup on the cts foot.There was no patient impact.Based on this assessment, no further remedial actions are required.This incident will be monitored through trending analysis.
Event or Problem Description
On (b)(6), 2026, erroneous results were reported for activated partial thromboplastin time (aptt) and prothrombin time (pt) for 18 patient samples tested on an acl top 500 cts analyzer (sn (b)(6) using hemosil synthasil (lot n0350874) and hemosil readiplastin 20 ml (lot n1248407).During the event period, additional patient samples were tested using the same reagent lots; however, those results did not require correction.A total of 50 patient results were retrospectively reviewed to assess potential impact.First occurrence (10:15 am - 2:00 pm) on 06apr2026: unusually low and failed pt and aptt results were initially observed.Quality control (qc) was not run at the time the atypical results were first noted.Once the issue was recognized, enhanced cleaning of all probes was performed, followed by qc testing.Pt reagent qc initially failed low but passed upon repeat testing and met laboratory-defined acceptance criteria.Aptt qc was within acceptable laboratory ranges on initial testing.Second occurrence (5:00 pm - 7:30 pm) on 06apr2026: during this period, pt reagent qc remained within laboratory-defined acceptable ranges.Aptt qc values recovered but remained at the low end of the laboratory's acceptable range.A service call was initiated to evaluate analyzer performance.The field service engineer (fse) observed a buildup of dried blood on the cts hold-down mechanism.Fse cleaned the hold-down and verified that the cts rinse pump was operating properly.System verification testing was completed successfully.No patient impact 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: 25072477
• Report Number: 1217183-2026-00005
• Device Sequence Number: 10748281
• Product Code: GFO
• UDI-Device Identifier: 08426950078920
• UDI-Public: (01)08426950078920(11)250401(17)270331(10)N0350874
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 05/04/2026

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: N0350874
• 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: 04/06/2026
• Initial Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2025
• 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