MAUDE Adverse Event Report: INSTRUMENTATION LABORATORY CO. ACL TOP 750 LAS; INSTRUMENT, COAGULATION, AUTOMATED

Model Number	2800-35
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	11/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A complaint was reported on (b)(6)2024 regarding acl top 750 las sn (b)(6), indicating that the probe scraped across fingertips of the technologist when she reached too far in past conveyor belt trying to align cuvettes on acl top 750 las sn (b)(6).It was noted that the glove the technician was wearing was still intact but a small scratch was seen on her fingertip.The incident is related to user error -not using precaution as instructed in the operator manual.The acl top series operator's manual confirmed that there are appropriate instructions and cautions as below: "warning piercing hazard: do not put hand inside instrument while it is in motion." "biohazard:the sample probe and piercer probe should be treated as biohazardous items.Laboratory precautions for biohazardous material should be taken when handling and disposing of these items".There was no known adverse effect from the scrape.The acl top 750 las 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
A complaint was reported on (b)(6)2024 regarding acl top 750 las sn (b)(6), indicating that the probe scraped across fingertips of the technologist when she reached too far in past conveyor belt trying to align cuvettes on acl top 750 las sn (b)(6).It was noted that the glove the technician was wearing was still intact but a small scratch was seen on fingertip.Technician went to emergency room and followed up with occupational health.Occupational health placed her on a pep for potential exposure for 28 days and scheduled follow-up.There was no known adverse effect from the scrape.

• Brand Name: ACL TOP 750 LAS
• Common Device Name: INSTRUMENT, COAGULATION, AUTOMATED
• Manufacturer (Section D): INSTRUMENTATION LABORATORY CO.; 180 hartwell road; bedford 01730
• Manufacturer (Section G): INSTRUMENTATION LABORATORY CO.; 180 hartwell road; bedford 01730
• Manufacturer Contact: anuja khan ; 180 hartwell road; bedford 01730
• MDR Report Key: 20762833
• Report Number: 1217183-2024-00008
• Device Sequence Number: 15600263
• Product Code: GKP
• UDI-Device Identifier: 08426950784050
• UDI-Public: (01)08426950784050(11)230911
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K242127
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/22/2024

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
• Device Model Number: 2800-35
• Device Catalogue Number: 00000280035
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/22/2024
• 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: Unknown