MAUDE Adverse Event Report: ABBOTT AUTOMATION SOLUTIONS GMBH GLP SAMPLE ACCESS LINE (SAL); CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE

Catalog Number 06Q27-01

Device Problems Unintended Movement (3026); Patient Data Problem (3197)

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

Event Date 05/09/2023

Event Type  malfunction  

Event Description

The customer observed discrepant results free t4, total t4, and atg results involving the glp sample access line (sal) for one sample when retested.The customer believes the retest results are correct.Ft4 initial result = 21.01 pmol/l, repeat result = 12.11 pmol/l (ref range: 9.01-19.05 pmol/l); tt4 initial result = 172.69 nmol/l, repeat result = 72.05 nmol/l (ref range: 62.68-150.84 nmol/l); ft3 initial result = 4.78 pmol/l, repeat result = 4.07 pmol/ l (ref range: 2.43-6.01 pmol/l); tt3 initial result = 1.42 nmol/l, repeat result = 1.26 nmol/l (ref range: 0.98-2.33 nmol/l); tsh initial result = 3.772 miu/l, repeat result = 3.409 miu/l (ref range: 0.350-4.96 miu/l); atg initial result = <0.5 ng/ml, repeat result = 15.9 ng/ml (ref range: 0-4.11 ng/ml); the lls showed that it may have not been the same sample.The customer reported the data was reviewed and they did not find the record of the sample being aspirated on the track of the i2000 instrument.The sample was aspirated on may 9 at 12:13:18, while the showed that at this moment the sample was at the buffer.No impact to patient management was reported.

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.E1 phone number continued information: (b)(6).All available patient information was included.Additional patient details are not available.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 us.

Manufacturer Narrative

The field service representative (fsr) tried troubleshooting by reviewing the logic back-end data and found that the reported sample may not have been the same sample.The track sample manager (tsm) data did not show that this sample was aspirated on the same track to the i2000 instrument.The sample was being aspirated but the tsm data showed that the sample was at the buffer as reported by the glp car data.The abbott automation solutions (aas) technical group performed an investigation based on the complaint information and log files received from the track.Aas determined that when the car passed the access point stat position and reached the routine-access point, it was reported as empty and generated an error.When another sample was processed with the same car, and since the previous sample instructions were not deleted, the i2000sr generated a different error and was sent to the error area.Since both samples were sent to the error area with the notification message, aas concluded there was no hazard risk.The instrument service history review revealed no additional service tickets associated with the issue.A review of tracking and trending did not identify any trends for the complaint issue.Labeling was reviewed and found to adequately address the issue.Based on the investigation, no systemic issue or deficiency for the glp sal abbott i2000sr or the glp car was identified.

Event Description

The customer observed discrepant results free t4, total t4, and atg results involving the glp sample access line (sal) for one sample when retested.The customer believes the retest results are correct.Ft4 initial result = 21.01 pmol/l, repeat result = 12.11 pmol/l (ref range: 9.01-19.05 pmol/l) tt4 initial result = 172.69 nmol/l, repeat result = 72.05 nmol/l (ref range: 62.68-150.84 nmol/l) ft3 initial result = 4.78 pmol/l, repeat result = 4.07 pmol/ l (ref range: 2.43-6.01 pmol/l) tt3 initial result = 1.42 nmol/l, repeat result = 1.26 nmol/l (ref range: 0.98-2.33 nmol/l) tsh initial result = 3.772 miu/l, repeat result = 3.409 miu/l (ref range: 0.350-4.96 miu/l) atg initial result = <0.5 ng/ml, repeat result = 15.9 ng/ml (ref range: 0-4.11 ng/ml) the lls showed that it may have not been the same sample.The customer reported the data was reviewed and they did not find the record of the sample being aspirated on the track of the i2000 instrument.The sample was aspirated on (b)(6) at 12:13:18, while the showed that at this moment the sample was at the buffer.No impact to patient management was reported.

• Brand Name: GLP SAMPLE ACCESS LINE (SAL)
• 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: 16966552
• MDR Text Key: 315856092
• Report Number: 3023268435-2023-00017
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 06/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 06Q27-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2023
• 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
• Treatment: GLP CAR, 04Z95-01.; GLP CAR, 04Z95-01.