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 Needle Stick/Puncture (2462)

Event Date 04/20/2023

Event Type  Injury  

Manufacturer Narrative

As part of the investigation, instrumentation laboratory (il) reviewed the on-line help documentation (operator's manual) and confirmed that there are appropriate instructions and warnings regarding the cleaning of the piercer probe assembly.The instructions include a warning not to place a finger under the acl top 500 cts specimen piercer since it is very sharp.The acl top 500 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 Description

The customer was injured during maintenance procedure "clean deep wash and clean cup area".The customer cleaned the sample cup area and after this operation turned up the footer and was injured with the piercer.The customer was wearing gloves.There was no known adverse effect from the puncture.

• 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
• MDR Report Key: 16948092
• MDR Text Key: 315408088
• Report Number: 1217183-2023-00001
• Device Sequence Number: 1
• Product Code: GKP
• UDI-Device Identifier: 08426950453499
• UDI-Public: 08426950453499
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K160276
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2023
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other