MAUDE Adverse Event Report: INSTRUMENTATION LABORATORY CO. ASSY, SYSTEM, ACL TOP 750 LAS; COAGULATION ANALYZER,

Model Number	2800-35
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	11/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the submitted photos shows one photo of the back of the cuvette waste drawer with a blood stain on the metal part of the plate spring and another photo of the user's bandaged finger.The incident is related to user error -not using precaution as instructed in the operator manual.The investigation confirmed that there are appropriate cautions regarding the activities of removing cuvettes from the waste area of the instrument.Per the operator manual the cuvette waste container is properly labeled as "cuvette waste is biohazardous.Use precautions when emptying the cuvette waste drawer.Refer to local and state regulations for disposal of potentially hazardous materials".Acl top 750 las performed as intended with no malfunction and its labeling provides appropriate instructions and cautions to the user.Therefore, no remedial action is indicated.
Event or Problem Description
A complaint from japan was reported on 11/11/2024 regarding assy, system, acl top 750 las (part number 00000280035) that mentions that a staff member was injured by a part in the back of the cuvette waste box from instrument acl top 750 las sn (b)(6).When she removed the box from the instrument and put her hand on it, she cut her hand on the metal part of the plate spring on the back of the box.It was noted that because of the risk of infection, a sticking plasters was put on wound site and injured staff member will be also taking post exposure drugs to prevent against hiv virus for 1 month.

• Brand Name: ASSY, SYSTEM, ACL TOP 750 LAS
• Common Device Name: COAGULATION ANALYZER,
• Manufacturer (Section D): INSTRUMENTATION LABORATORY CO.; 180 hartwell road; bedford 01730
• Manufacturer (Section G): INSTRUMENTATION LABORATORY CO.; 180 hartwell road; bedford 01730
• Manufacturer Contact: anuja khan ; 180 hartwell road; bedford 01730
• MDR Report Key: 20745498
• Report Number: 1217183-2024-00007
• Device Sequence Number: 21021645
• Product Code: GKP
• UDI-Device Identifier: 08426950784050
• UDI-Public: (01)08426950784050(11)240103
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K242127
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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?: No
• Device Model Number: 2800-35
• Device Catalogue Number: 00000280035
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2024
• Initial Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown