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

Model Number 2800-60

Device Problem Use of Device Problem (1670)

Patient Problem Needle Stick/Puncture (2462)

Event Date 05/22/2020

Event Type  Injury  

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 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
• Type of Device: COAGULATION ANALYZER
• Manufacturer (Section D): INSTRUMENTATION LABORATORY COMPANY; 180 hartwell road; bedford, ma
• Manufacturer (Section G): INSTRUMENTATION LABORATORY COMPANY; 180 hartwell road; bedford, ma
• Manufacturer Contact: reba daoust ; 180 hartwell road; bedford, ma ; 4080329
• MDR Report Key: 10145652
• MDR Text Key: 196919791
• Report Number: 1217183-2020-00002
• Device Sequence Number: 1
• Product Code: GKP
• UDI-Device Identifier: 08426950556916
• UDI-Public: 08426950556916
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160276
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2800-60
• Device Catalogue Number: 00000280060
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 40 YR