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

Model Number	2800-45
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	06/28/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: COAGULATION ANALYZER
• Manufacturer (Section D): INSTRUMENTATION LABORATORY CO.; 180 hartwell road; bedford, ma
• MDR Report Key: 10303571
• Report Number: 1217183-2020-00003
• Device Sequence Number: 19502833
• Product Code: GKP
• UDI-Device Identifier: 08426950729242
• UDI-Public: 08426950729242
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/21/2020

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: 2800-45
• Device Catalogue Number: 00000280045
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 07/21/2020
• 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