MAUDE Adverse Event Report: INSTRUMENTATION LABORATORY CO. ACL TOP 500 CTS; COAGULATION ANALYZER

Model Number 2800-40

Device Problem Use of Device Problem (1670)

Patient Problem Abrasion (1689)

Event Date 10/04/2023

Event Type  Injury  

Manufacturer Narrative

The technical support representative instructed 'carefully' to remove the specimen from the probe.Operator received a small cut to finger through gloved hand during trouble shooting the instrument.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.

Event Description

Customer injured finger while removing sample tube from cts sample probe while troubleshooting.Customer was wearing gloves at the time.Customer went to occupational health to be evaluated.

• Brand Name: ACL TOP 500 CTS
• Type of Device: COAGULATION ANALYZER
• 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; bedford, MA 01730 ; 7818614451
• MDR Report Key: 17934001
• MDR Text Key: 325679658
• Report Number: 1217183-2023-00004
• Device Sequence Number: 1
• Product Code: GKP
• UDI-Device Identifier: 08426950453499
• UDI-Public: 08426950453499
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K160276
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2800-40
• Device Catalogue Number: 00000280040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male