MAUDE Adverse Event Report: INSTRUMENTATION LABORATORY CO. HEMOSIL RECOMBIPLASTIN 2G (8ML); PROTHROMBIN TIME TEST

Catalog Number	0020002950
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is ongoing.Final follow-up will be filed when completed.
Event or Problem Description
A patient with a history of cabg and mvr (2012), on long-term acitrom (3 mg/day), hypertension, and dyslipidemia, was admitted on (b)(6) 2025, with a left-sided hyperacute small thalamic infarct.After treatment and discharge, he returned for follow-up on (b)(6) 2025.He has done pt and aptt test on 6th of april 2025, and he got the inr of 6.2.Inr values varied significantly across different testing sites: 6.2 (initial), 3.47, and 4.59, raising concerns about reliability and anticoagulation control.
Additional Manufacturer Narrative
Screenshots and reports from the acl elite pro were provided for the investigation, as well as the certificate of analysis (coa) for hemosil recombiplastin 2g (8ml) lot n1137324.The coa confirmed that the reagent met all specifications for product release.A review of the submitted daily qc report showed quality controls were tested for hemosil recombiplastin 2g on (b)(6) 2025 and recovered within the acceptance ranges prior to running the sample in question.The screenshot confirmed the reported results which generated no errors or warnings.Unable to determine the cause of the discrepant result.There was no known patient impact.Based on the investigation, there was no problem found with the reagent; therefore no remedial action is required.

• Brand Name: HEMOSIL RECOMBIPLASTIN 2G (8ML)
• Common Device Name: PROTHROMBIN TIME TEST
• 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; bedrord, MA 01730 ; 7818614451
• MDR Report Key: 21929431
• Report Number: 1217183-2025-00030
• Device Sequence Number: 9022310
• Product Code: GJS
• UDI-Device Identifier: 08426950453079
• UDI-Public: (01)08426950453079(11)240101(17)251231(10)N1137324
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K132722
• 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): 07/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 12/31/2025
• Device Catalogue Number: 0020002950
• Device Lot Number: N1137324
• 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: 04/06/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male