MAUDE Adverse Event Report: INSTRUMENTATION LABORATORY CO. ACL TOP 550 CTS; COAGULATION ANALYZER

Model Number	2800-45
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	10/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint indicates that an operator accidentally punctured his finger on the probe while trying to unlock it.It was also noted that a colleague placed a closed tube in the wrong rack (without a cap) and the needle got stuck, he pricked his finger when unlatching the perforator and the tube.The acl top series operator's manual confirmed that there are appropriate instructions and cautions regarding the activities of a stuck or jammed cts piercer probe in the cap of a primary sample tube.Per the acl top family 50 series operator's manual; " warning piercing hazard: do not put hand inside instrument while sample arm is in motion.Caution biohazard: in the unlikely event that the cts piercer probe gets stuck or jammed in the cap of a primary sample tube, do not attempt to remove the cap.Call service for assistance.The cts piercer probe assembly is delicate, very sharp, and biohazardous.The removal of a stuck cap from the piercer probe could cause personal injury or damage to the instrument".No remedial action required.The acl top 550 cts performed as intended with no malfunction and its labeling provides appropriate warnings to the user regarding the hazard.Therefore, no remedial action is indicated at this time.
Event or Problem Description
A complaint was filed on october 25, 2024 regarding acl top 550 cts sn (b)(6) indicating user accidentally punctured his finger on probe while trying to unlock it.Complaint mentioned that a colleague placed a closed tube in the wrong rack (without a cap) and the needle got stuck, and the user pricked his finger when unlatching the perforator and the tube.There was no known adverse effect from the puncture.

• Brand Name: ACL TOP 550 CTS
• 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: 20622329
• Report Number: 1217183-2024-00006
• Device Sequence Number: 12980271
• Product Code: GKP
• UDI-Device Identifier: 08426950729242
• UDI-Public: (01)08426950729242(11)190304
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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
• Type of Report: Initial
• Report Date (Section B): 11/06/2024

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: 2800-45
• Device Catalogue Number: 00000280045
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2024
• Initial Report FDA Received Date: 11/06/2024
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male