MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS TROPONIN T HS; IMMUNOASSAY METHOD, TROPONIN SUBUNIT

Catalog Number 08469873190

Device Problems High Test Results (2457); Low Test Results (2458); Non Reproducible Results (4029)

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

Event Date 02/06/2023

Event Type  malfunction  

Event Description

The initial reporter stated they received discrepant results for an unspecified number of patient samples tested with elecsys troponin t hs on two cobas e 801 analytical units between (b)(6) 2023 and (b)(6) 2023.Examples of patient data are provided for 5 patient samples.The first sample resulted in trponin t values of 16.2 ng/l and repeated as 9.0 ng/l on the first e 801 system.The sample was repeated a third time on an unknown system, resulting in a value of 12.1 ng/l.The second sample resulted in troponin t values of 6.5 ng/l and 7.0 ng/l when tested on the first e 801 system on (b)(6) 2023.The sample was repeated twice on the second e 801 analyzer, resulting in troponin t values of 14.8 ng/l and 7.1 ng/l.The sample was repeated five additional times on an unknown system, resulting in values of 14.8 ng/l, 10.8 ng/l, 20.7 ng/l, 7.9 ng/l, and 6.3 ng/l.The average of the last 2 values of 7.9 ng/l and 6.3 ng/l was reported outside of the laboratory as 7.1 ng/l.The third sample resulted in troponin t values of 47.7 ng/l and 128.0 ng/l on the first e 801 system on (b)(6) 2023.The sample was repeated a third time on an unknown system, resulting in a value of 129 ng/l.The fourth sample resulted in a troponin t values of 10.6 ng/l and 6.8 ng/l when tested on the first e 801 system on (b)(6) 2023.A third measurement of the sample was performed on an unknown system, resulting in a value of 6.55 ng/l.The fourth sample resulted in a troponin t values of 10.5 ng/l and 5.6 ng/l when tested on the second e 801 system on (b)(6) 2023.A third measurement of the sample was performed on an unknown system, resulting in a value of 4.25 ng/l.

Manufacturer Narrative

A serial number of (b)(6) was provided for one of the e 801 analyzers, but it is not known which of the two systems this applies to.The serial number of the second e 801 analyzer was requested, but not provided.The following troponin t reagent lot numbers were used on the first e 801 analyzer: lot 639807 between on (b)(6) 2023, lot 642405 between on (b)(6) 2023, lot 688155 between on(b)(6) 2023.The following troponin t reagent lot numbers were used on the second e 801 analyzer: lot 639807 between on (b)(6) 2023, lot 642405 between on (b)(6) 2023, lot 688155 between on (b)(6) 2023, lot 642405 on (b)(6) 2023, lot 688155 between on (b)(6) 2023.The reagent expiration dates were requested, but not provided.The investigation is ongoing.

Manufacturer Narrative

Upon review of the alarm trace from july to november 2023, multiple sample short, sample clot, and sample foam alarms were observed.These alarms indicate a possible sample quality issue.Sample camera images from the analyzer showed evidence of clots, fibrin, fibrinogen, particles, or dust for a majority of samples.The investigation could not identify a product problem.The cause of the event could not be determined.The issue is consistent with incorrect pre-analytic sample handling.

Manufacturer Narrative

The customer performed a study comparing troponin t measurements obtained with patient samples collected in standard heparin plasma tubes that are strongly centrifuged and samples collected in barricor heparin plasma tubes.In total, there were 13 troponin t measurements from 7 patients that were =5 ng/l higher in comparison to a different measurement method.Of these 7 patients, there was 1 patient who was ultimately diagnosed with acs and medical intervention was also initiated.There was no allegation of harm to any patients.

• Brand Name: ELECSYS TROPONIN T HS
• Type of Device: IMMUNOASSAY METHOD, TROPONIN SUBUNIT
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18049567
• MDR Text Key: 327371822
• Report Number: 1823260-2023-03492
• Device Sequence Number: 1
• Product Code: MMI
• Combination Product (y/n): Y
• Reporter Country Code: NL
• PMA/PMN Number: K201441NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/15/2023

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: 08469873190
• Device Lot Number: 639807
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2023
• Initial Date FDA Received: 11/01/2023
• Supplement Dates Manufacturer Received: 11/14/2023; 12/15/2023
• Supplement Dates FDA Received: 12/08/2023; 12/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1