MAUDE Adverse Event Report: INSTRUMENTATION LABORATORY CO. ACL TOP 750 CTS; COAGULATION ANALYZER

Model Number	2800-55
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An evaluation of the acl top 750 cts by the software development team determined that the barcode was not misread due to a software defect or instrument malfunction.The software development team indicated that a barcode may be misread due to human factors such as when a label is twisted/tilted hiding part of the barcode or if the printed labels are of poor quality.It is likely that the barcode was not placed properly and therefore was misread when placed on the sample rack.Acl top family 50 series operator's manual, in chapter 4 indicates the proper placement in "bar code label placement".No remedial action required.
Event or Problem Description
The complaint stated that there was a malfunction of the barcode reader on the acl top 750 cts instrument.The instrument barcode reader misread a patient sample identification number and the sample results were assigned to another patient.The results were not transmitted to the laboratory information system (lis) and there was no patient impact as a result of this event.

• Brand Name: ACL TOP 750 CTS
• Common Device Name: COAGULATION ANALYZER
• Manufacturer (Section D): INSTRUMENTATION LABORATORY CO.; 180 hartwell road; bedford MA 01730 2443
• MDR Report Key: 11097915
• Report Number: 1217183-2020-00004
• Device Sequence Number: 630726
• Product Code: GKP
• UDI-Device Identifier: 08426950784067
• UDI-Public: 08426950784067
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K150877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/30/2020

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: 2800-55
• Device Catalogue Number: 00000280055
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2020
• Initial Report FDA Received Date: 12/30/2020
• 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