MAUDE Adverse Event Report: INSTRUMENTATION LABORATORY COMPANY ACL TOP 300 CTS; COAGULATION ANALYZER

Model Number	2800-60
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	05/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As part of the investigation, instrumentation laboratory (il) reviewed the online help documentation (operator's manual).Investigation confirmed that there are appropriate instructions and cautions regarding the activities: adjusting probe coordinates and cleaning of the cts foot.The cautions indicated that the procedure to adjusting probe coordinates should only be performed by individuals who have been properly trained.The instructions for cts foot cleaning include a piercing warning for the acl top cts foot.The manual has these two operations as independent operations and should not have been combined.The acl top 300 cts performed as intended with no malfunction and its labeling provides appropriate caution/warning to the user.Therefore, no remedial action is indicated.
Event or Problem Description
It was reported that a customer was performing reagent probe coordinate adjustment on the acl top 300 cts analyzer.The user noticed the cts foot was dirty and preceded to clean the cts foot.While attempting to clean the cts foot, the user's hand was cut.Customer was wearing gloves at time of incident.She went to emergency room per lab policy.

• Brand Name: ACL TOP 300 CTS
• Common Device Name: COAGULATION ANALYZER
• Manufacturer (Section D): INSTRUMENTATION LABORATORY COMPANY; 180 hartwell road; bedford, ma
• MDR Report Key: 10145652
• Report Number: 1217183-2020-00002
• Device Sequence Number: 14249252
• Product Code: GKP
• UDI-Device Identifier: 08426950556916
• UDI-Public: 08426950556916
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K160276
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/11/2020

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: 2800-60
• Device Catalogue Number: 00000280060
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2020
• Initial Report FDA Received Date: 06/11/2020
• 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
• Patient Age: 40 YR