MAUDE Adverse Event Report: ABBOTT AUTOMATION SOLUTIONS GMBH GLP TRACK END; CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE

Catalog Number 06Q42-01

Device Problem Low Test Results (2458)

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

Event Date 07/18/2022

Event Type  malfunction  

Manufacturer Narrative

This report is being filed on an international product, product name glp track end, list number 06q42-01, which has a same/similar component of the modular glp systems track registered in the us, list number 04z96-51.Note: the glp systems track is not yet marketed in the us complete information from patient identifier multiple = sid (b)(6) and sid (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer noticed an error message on the sal screen of the glp track but did not perform any intervening action for the error.The customer first loaded the track, but they suspected the result and reloaded it using the alinity racks without track and the results were mismatched.The logs were checked and this error message was found ¿arrival of sample (b)(6) on car (b)(6) at access point 0 and unit in acquiring state, protentional contamination¿.The following results were provided in the attachments.Sid (b)(6) na initial result 116, repeat 138.Sid (b)(6) na initial result 118, repeat 138.No impact to patient management was reported.

Manufacturer Narrative

This follow up is being submitted to include the initial coding in section h6 for component code, type of investigation, investigation findings and investigation conclusions that were not included in the initial report.

Manufacturer Narrative

Further troubleshooting such as replacement of the accesspoint basic associated with the sal alinity interface was suggested.The issue was escalated for investigation.Review of tickets did not find any other complaints related to the current issue for the accesspoint basic related to the issue.Trending review did not identify any trends for the complaint issue.This is the sole complaint for this issue.Current labeling provides the procedure and instructions for the glp track system on the accesspoint basic and functions of transporting sample tubes for analysis.The abbott automation solutions (aas) technical group performed an investigation based on the complaint information and were unable to detect any abnormal behavior by the track system.A request from aas was made to retrieve the sal alinity system logs but were unable to retrieve those for analysis.Aas were unable to find any other occurrences of this issue and determined that the system was operating within expected behavior.Based on all reviewed data, we conclude that there is no product deficiency with the accesspoint basic identified in this complaint.

• Brand Name: GLP TRACK END
• Type of Device: CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
• Manufacturer (Section D): ABBOTT AUTOMATION SOLUTIONS GMBH; sachsenkamp 5; hamburg 20097 ; GM 20097
• Manufacturer (Section G): ABBOTT AUTOMATION SOLUTIONS GMBH; sachsenkamp 5; hamburg 20097 ; GM 20097
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 15199000
• MDR Text Key: 305334773
• Report Number: 3023268435-2022-00003
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: TC
• PMA/PMN Number: K213486
• 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,Followup,Followup
• Report Date: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 06Q42-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/18/2022
• Initial Date FDA Received: 08/10/2022
• Supplement Dates Manufacturer Received: 09/06/2022; 10/06/2022
• Supplement Dates FDA Received: 09/28/2022; 10/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACCESSPOINT BASIC, G-41226-01, UNKNOWN; ACCESSPOINT BASIC, G-41226-01, UNKNOWN; ACCESSPOINT BASIC, G-41226-01, UNKNOWN