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

Model Number 2800-55

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/10/2020

Event Type  Injury  

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 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
• Type of Device: COAGULATION ANALYZER
• Manufacturer (Section D): INSTRUMENTATION LABORATORY CO.; 180 hartwell road; bedford MA 01730 2443
• Manufacturer (Section G): INSTRUMENTATION LABORATORY CO.; 180 hartwell road; bedford MA 01730 2443
• Manufacturer Contact: reba daoust ; 180 hartwell road; bedford, MA 01730-2443 ; 9784080329
• MDR Report Key: 11097915
• MDR Text Key: 225765409
• Report Number: 1217183-2020-00004
• Device Sequence Number: 1
• Product Code: GKP
• UDI-Device Identifier: 08426950784067
• UDI-Public: 08426950784067
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K150877
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2800-55
• Device Catalogue Number: 00000280055
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2016
• 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