MAUDE Adverse Event Report: ABBOTT AUTOMATION SOLUTIONS GMBH TRACK SAMPLE MANAGER (TSM); CALCULATOR/ DATA PROCESSING MODULE, FOR CLINICAL USE

Catalog Number 06Q29-01

Device Problem Patient Data Problem (3197)

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

Event Date 06/07/2023

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Complete information for section a1 patient identifier = (b)(6)and (b)(6).

Event Description

The customer observed that the twm (track workflow manager) on the glp sent one sample without centrifuging it first to an analyzer because its sid from today matched an sid from the previous year and marked the sample as already centrifuged from data from last year.Another sid had test ordered from same sid from the previous year added to today¿s order.No results were reported out of the laboratory.The following data was provided: sid (b)(6) went to analyzer without centrifugation because the sample is marked as centrifugated from last year.Sid (b)(6) has emat test from today and hcv from previous year on same barcode.No impact to patient management was reported.

Manufacturer Narrative

The field service representative (fsr) reported a failure of the glp trk wf mr 201, list number 06s86-07, serial number (b)(6), where samples are not erased from the previous year.Upon further investigation, the fsr observed that the customer was using the same sample identification (sid) from the previous year which led to samples being misrouted, not centrifuged and possibly wrong results being released because the information from the previous year had not been deleted for that sid.The issue was resolved by canceling the twm database and restoring the samples in the archive.A review of tracking and trending for the glp trk wf mr 201, list number 06s86-07 did not identify any trends.Labeling was reviewed and found to be adequate.The abbott automation solutions (aas) technical group performed an investigation and were able to show that the problem is not a deficiency, as no requirement is violated.Based on the available information, a deficiency was not identified.A malfunction occurred as the device did not meet performance specifications or perform as intended at the customer site.No systemic or product deficiency was identified for the glp trk wf mr 201, list number 06s86-07, related to the current issue.

Event Description

The customer observed that the twm(track workflow manager) on the glp sent one sample without centrifuging it first to an analyzer because its sid from today matched an sid from the previous year and marked the sample as already centrifuged from data from last year.Another sid had test ordered from same sid from the previous year added to today¿s order.No results were reported out of the laboratory.The following data was provided: (b)(6) went to analyzer without centrifugation because the sample is marked as centrifugated from last year.(b)(6) has emat test from today and hcv from previous year on same barcode.No impact to patient management was reported.

• Brand Name: TRACK SAMPLE MANAGER (TSM)
• 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: 17135241
• MDR Text Key: 317246021
• Report Number: 3023268435-2023-00020
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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
• Report Date: 07/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 06Q29-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2023
• 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