MAUDE Adverse Event Report: INSTRUMENTATION LABORATORY CO. ACL TOP 350 CTS; COAGULATION ANALYZER, PRODUCT CODE: GKP

Model Number	2800-65
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	08/17/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As part of the investigation, instrumentation laboratory (il) reviewed the acl top family 50 series operator's manual.The investigation 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".The acl top 350 cts performed as intended with no malfunction and its labeling provides appropriate instructions and cautions to the user.Therefore, no remedial action is indicated.
Event or Problem Description
It was reported that an acl top 350 cts instrument operator received a scratch on the thumb of her gloved hand while troubleshooting to remove a stuck sample probe.A sample tube was loaded into an incorrect sample rack, thus resulting in the sample probe being stuck in the sample tube.The tech scratched her thumb on the reagent probe while attempting to remove the stuck sample probe.The staff member received a band aid and anti-virus/antibiotic treatment after reporting this incident.She also filed an incident report with the hospital.

• Brand Name: ACL TOP 350 CTS
• Common Device Name: COAGULATION ANALYZER, PRODUCT CODE: GKP
• 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: reba daoust ; 180 hartwell road; bedford, MA 01730
• MDR Report Key: 15362713
• Report Number: 1217183-2022-00004
• Device Sequence Number: 5518280
• Product Code: GKP
• UDI-Device Identifier: 08426950784081
• UDI-Public: 08426950784081
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K150877
• 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): 09/06/2022

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: 2800-65
• Device Catalogue Number: 00000280065
• 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: 08/18/2022
• Initial Report FDA Received Date: 09/06/2022
• 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: Female