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 Delayed Program or Algorithm Execution (4034)

Patient Problem Insufficient Information (4580)

Event Date 07/11/2023

Event Type  Death  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.

Event Description

The customer observed on (b)(6) 2023 the sample tubes were buffering in circles on the chain involving the glp track sample manager (tsm).The glims/re and re / tsm connections were active and the routine engine seemed to be working normally.The customer stopped, restarted tsm, and the system restarted.Additionally, the customer observed all the tubes would go to the buffer and the tsm no longer sent an in message to the re.The customer reported this incident seriously disrupted the activity, all the tubes were taken out of the chain, manually sorted, reloaded for re-analysis of the routes.The customer reported that the patient results were reported with a 2-3 hour delay to the physicians; however, the customer reported there was no impact to patients¿ treatment or medication.Additional information was provided on 19jul2023 that a 75-year-old male patient died that required a troponin and hemoglobin result to be analyzed; however, it is unclear if it was due to any delayed or missed treatment.No information was provided regarding the circumstances of the death.The customer reported the patient was followed by hemato-cancerology and the samples were collected at the home / outpatient.It is unknown what time the samples arrived at the lab.The following results were provided: troponin result was 47 pg/ml (released and transmitted at 6:00 p.M.).Hemoglobin result was 5.5 g/dl (transmitted at 7:00 p.M.).No further information has been provided.

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Additional information: this report is being filed on an international product, glp sample access line (sal), list number 06q27-01, 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 u.S.

Event Description

The customer observed on 11jul2023 the sample tubes were buffering in circles on the chain involving the glp track sample manager (tsm).The glims/re and re/tsm connections were active and the routine engine seemed to be working normally.The customer stopped, restarted tsm, and the system restarted.Additionally, the customer observed all the tubes would go to the buffer and the tsm no longer sent an in message to the re.The customer reported this incident seriously disrupted the activity, all the tubes were taken out of the chain, manually sorted, reloaded for re-analysis of the routes.The customer reported that the patient results were reported with a 2-3 hour delay to the physicians; however, the customer reported there was no impact to patients¿ treatment or medication.Additional information was provided on 19jul2023 that a 75-year-old male patient died that required a troponin and hemoglobin result to be analyzed; however, it is unclear if it was due to any delayed or missed treatment.No information was provided regarding the circumstances of the death.The customer reported the patient was followed by hemato-cancerology and the samples were collected at the home/outpatient.It is unknown what time the samples arrived at the lab.The following results were provided: troponin result was 47 pg/ml (released and transmitted at 6:00 p.M).Hemoglobin result was 5.5 g/dl (transmitted at 7:00 p.M).No further information has been provided.

Manufacturer Narrative

The incident was reviewed which included the information provided in the complaint text and the track logs provided by the customer.The timeline within the logs was reviewed and found that the associated track sample manager (tsm) response times were within the recommended ranges.The investigation did note that no issues were observed and there was very low activity on the track.It was noted that the logs for the associated event were not provided and therefor unavailable to investigate.A review of tickets did not find any other complaints related to the current issue.Trending review did not identify any trends for the issue for the product.Labeling was reviewed and sufficiently addresses the customer's issue.Based on the investigation, no systemic issue or deficiency with the glp track sample manager was identified.All available patient information was included.Additional patient details are not available.

Event Description

The customer observed on (b)(6) 2023 the sample tubes were buffering in circles on the chain involving the glp track sample manager (tsm).The glims/re and re/tsm connections were active and the routine engine seemed to be working normally.The customer stopped, restarted tsm, and the system restarted.Additionally, the customer observed all the tubes would go to the buffer and the tsm no longer sent an in message to the re.The customer reported this incident seriously disrupted the activity, all the tubes were taken out of the chain, manually sorted, reloaded for re-analysis of the routes.The customer reported that the patient results were reported with a 2-3 hour delay to the physicians; however, the customer reported there was no impact to patients¿ treatment or medication.Additional information was provided on (b)(6) 2023 that a 75-year-old male patient died that required a troponin and hemoglobin result to be analyzed; however, it is unclear if it was due to any delayed or missed treatment.No information was provided regarding the circumstances of the death.The customer reported the patient was followed by hemato-cancerology and the samples were collected at the home/outpatient.It is unknown what time the samples arrived at the lab.The following results were provided: troponin result was 47 pg/ml (released and transmitted at 6:00 p.M.) hemoglobin result was 5.5 g/dl (transmitted at 7:00 p.M.) no further information has been provided.

• 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: 17496774
• MDR Text Key: 320750451
• Report Number: 3023268435-2023-00029
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: LU
• 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: 09/07/2023

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 06Q29-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/10/2023
• Initial Date FDA Received: 08/10/2023
• Supplement Dates Manufacturer Received: 08/10/2023; 09/01/2023
• Supplement Dates FDA Received: 08/10/2023; 09/07/2023
• 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
• Patient Outcome(s): Death
• Patient Age: 75 YR
• Patient Sex: Male