MAUDE Adverse Event Report: INSTRUMENTATION LABORATORY CO. ACL TOP 550 CTS; COAGULATION ANALYZER

Model Number 2800-45

Device Problem Use of Device Problem (1670)

Patient Problem Needle Stick/Puncture (2462)

Event Date 06/28/2020

Event Type  Injury  

Manufacturer Narrative

As part of the investigation, instrumentation laboratory (il) reviewed the online help documentation (acl top family 50 series operator's manual).The investigation confirmed that there are appropriate instructions and cautions regarding the activities of cleaning and removing cuvettes from the waste area of the instrument.Per the acl top family 50 series operator's manual, the operator action to address the two alarms presented during the incident is to perform a recovery and if the alarm persists to call for service.Il confirmed that the laboratory technician did not call il service or the technical service helpline while performing these activities.The acl top 550 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 Description

It was reported that an acl top 550 cts instrument operator developed a laceration resulting in bleeding on the finger of her gloved hand.This incident occurred while troubleshooting to clean and remove cuvettes from the waste area of the instrument.The staff member received medical attention in the emergency department at the hospital and filed an incident report.No stitches were necessary.The staff member was placed on medication for (b)(6) prophylaxis.

• Brand Name: ACL TOP 550 CTS
• Type of Device: COAGULATION ANALYZER
• Manufacturer (Section D): INSTRUMENTATION LABORATORY CO.; 180 hartwell road; bedford, ma
• Manufacturer (Section G): INSTRUMENTATION LABORATORY COMPANY; 180 hartwell road; bedford,
• Manufacturer Contact: reba daoust ; 180 hartwell road; bedford, ma ; 8614597
• MDR Report Key: 10303571
• MDR Text Key: 199738413
• Report Number: 1217183-2020-00003
• Device Sequence Number: 1
• Product Code: GKP
• UDI-Device Identifier: 08426950729242
• UDI-Public: 08426950729242
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150877
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2800-45
• Device Catalogue Number: 00000280045
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2017
• 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