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

Model Number	2800-40
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	04/20/2023
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 1217183-2023-00001
• Device Sequence Number: 12400776
• Product Code: GKP
• UDI-Device Identifier: 08426950453499
• UDI-Public: 08426950453499
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K160276
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/17/2023

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
• Operator of Device: Health Professional
• Device Model Number: 2800-40
• Device Catalogue Number: 00000280040
• 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: 04/21/2023
• Initial Report FDA Received Date: 05/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2015
• Is the Device Labeled for Single Use? (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: Unknown