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

Catalog Number 09315357190

Device Problems False Negative Result (1225); Low Test Results (2458); Non Reproducible Results (4029)

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

Event Date 09/07/2023

Event Type  malfunction  

Event Description

There was an allegation of questionable elecsys troponin t hs assay results for 13 patient samples on a cobas e 801 analytical unit.For sample 1, the initial result was 3.66 pg/ml.The repeat result was 19.9 pg/ml.For sample 2, the initial result was 4.75 pg/ml.The sample was repeated on an e411 analyzer and the repeat results were 1251 pg/ml and 1193 pg/ml.For sample 3, the initial result was 5.72 pg/ml.The repeat result was 12.6 pg/ml.For sample 4, the initial result was 4.33 pg/ml.The repeat result was 13.0 pg/ml.For sample 5, the initial result was 4.90 pg/ml.The repeat result was 10.1 pg/ml.For sample 6, the initial result was 4.29 pg/ml.The repeat result was 114 pg/ml.For sample 7, the initial result was 3.25 pg/ml.The repeat result was 316 pg/ml.For sample 8, the initial result was 5.34 pg/ml.The repeat result was 112 pg/ml.For sample 9, the initial result was 3.52 pg/ml.The repeat result was 14.0 pg/ml.For sample 10, the initial result was 5.26 pg/ml.The repeat result was 28.5 pg/ml.For sample 11, the initial result was 4.11 pg/ml.The repeat result was 7.24 pg/ml.For sample 12, the initial result was 4.01 pg/ml.The repeat result was 10.3 pg/ml.For sample 13, the initial result was 6.99 pg/ml.The repeat result was 26.8 pg/ml.The repeat results were deemed correct.No questionable results were reported outside of the laboratory.

Manufacturer Narrative

The analyzer serial number is (b)(6).The calibration and qc data provided was acceptable.The alarm trace showed a sample short alarm and four sample foam detection alarms.The investigation is ongoing.

Manufacturer Narrative

It was found that the customer did not perform qc when the reagent pack was first installed.Qc was only performed when there were (b)(4) tests remaining on (b)(6) 2023.Per product labeling, "controls for the various concentration ranges should be run individually at least once every 24 hours when the test is in use, once per cobas e pack, and following each calibration." based on the available data, a general reagent issue could be excluded.The investigation did not identify a product problem.The root cause of the event could not be determined.

• 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: 17871370
• MDR Text Key: 325098526
• Report Number: 1823260-2023-03186
• Device Sequence Number: 1
• Product Code: MMI
• Combination Product (y/n): Y
• Reporter Country Code: CH
• 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
• Report Date: 11/08/2023

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 Expiration Date: 11/30/2023
• Device Catalogue Number: 09315357190
• Device Lot Number: 64240502
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/07/2023
• Initial Date FDA Received: 10/04/2023
• Supplement Dates Manufacturer Received: 10/19/2023
• Supplement Dates FDA Received: 11/08/2023
• 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
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian