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

Model Number	2800-35
Medical Device Problem Code	Data Problem (3196)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the acl top 750 las analyzer incorrectly read a patient sample bar code on (b)(6) 2022.The operator was reviewing outstanding requests on the lis and no results were present for sample number (b)(6) on lis.The operator removed the physical tube and viewed the barcode label, the sample that had read as (b)(6) on the acl top sample list was actually eye-readable as (b)(6).On checking the general log for the period on time involved, there was no non-identified sample error recorded during this time.Sample id (b)(6) had no demographic uploaded to acl top from hemohub.The operator reprinted the bar codes for each sample number and loaded on the acl top.Both sample barcodes read correctly.No patient impact.
Additional Manufacturer Narrative
Based on the customer reported incident, instrumentation laboratory company conducted an investigation that included a review of their acl top 750 las instrument data backup.This investigation was unable to establish a definitive cause of the reported mis-read patient sample bar codes.Further, the customer confirmed that all reagent barcodes, sample rack barcodes and reagent rack barcodes were scanning correctly and that upon re-printing of the mis-read patient barcodes, the patient barcodes were read correctly by the acl top 750 las.There was no patient impact as a result of the alleged mis-read patient sample bar codes.Accordingly, a risk assessment determined that no remedial action is indicated.

• Brand Name: ACL TOP 750 LAS
• Common Device Name: COAGULATION ANALYZER
• Manufacturer (Section D): INSTRUMENTATION LABORATORY CO.; 180 hartwell road; bedford MA 01730
• Manufacturer (Section G): INSTRUMENTATION LABORATORY CO.; 180 hartwell road; bedford MA 01730
• Manufacturer Contact: reba daoust ; 180 hartwell road; bedford, MA 01730
• MDR Report Key: 15578943
• Report Number: 1217183-2022-00006
• Device Sequence Number: 12467848
• Product Code: GKP
• UDI-Device Identifier: 08426950784050
• UDI-Public: 08426950784050
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K150877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2022

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: 2800-35
• Device Catalogue Number: 00000280035
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2022
• Supplement Date Received by Manufacturer: 09/15/2022
• Initial Report FDA Received Date: 10/11/2022
• Supplement Report FDA Received Date: 11/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown