MAUDE Adverse Event Report: INSTRUMENTATION LABORATORY CO. ACL TOP 750 CTS; COAGULATION ANALYZER

Model Number	2800-55
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	04/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As part of the investigation, service was dispatched for acl top 750 cts analyzer and instrumentation laboratory (il) reviewed the online 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 750 cts specimen piercer since it is very sharp.The acl top 750 cts performed as intended with no malfunction and its labeling provides appropriate warnings to the user regarding the hazard of the sample piercer.Therefore, no remedial action is indicated at this time.
Event or Problem Description
It was reported that a customer was performing the manual needle cleaning procedure of the piercer probe assembly on the acl top 750 cts analyzer and punctured his finger.Following hospital protocol, treatment was provided in the emergency room of the hospital.Medicament and bandage were provided to the injured finger.There was no known adverse effect from the puncture.

• Brand Name: ACL TOP 750 CTS
• Common Device Name: COAGULATION ANALYZER
• Manufacturer (Section D): INSTRUMENTATION LABORATORY CO.; 180 hartwell road; bedford MA 01730
• MDR Report Key: 11759548
• Report Number: 1217183-2021-00001
• Device Sequence Number: 11920959
• Product Code: GKP
• UDI-Device Identifier: 08426950784067
• UDI-Public: 08426950784067
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K150877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/03/2021

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: 2800-55
• Device Catalogue Number: 00000280055
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 05/03/2021
• 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