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

Catalog Number 09315349190

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

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

Event Date 02/17/2022

Event Type  malfunction  

Event Description

The initial reporter received discrepant elecsys troponin t hs stat results for one patient sample tested on a cobas 6000 e601 module.The initial result at 8:47 am was 7.29 pg/ml.The initial result was not reported outside of the laboratory.The first repeat result at 9:47 am was 6.60 pg/ml.The second repeat result at 10:04 am was 23.56 pg/ml.This result was reported outside of the laboratory.The third repeat result at 12:10 pm was 26.02 pg/ml.The fourth repeat result at 12:20 pm was 33.21 pg/ml with a data flag.The fifth repeat result at 4:48 pm was 33.97 pg/ml.The sixth repeat result at 4:52 pm was 35.84 pg/ml.The e601 module serial number was (b)(4).

Manufacturer Narrative

The field service engineer (fse) and the field application specialist (fsa) collected data regarding the patient and the sample.The fse and fsa collected 5 sample tubes to send to other laboratories where the customer has installed instruments, to verify which of these results was correct.Five samples were run between the platforms with acceptable results.The fse performed a general platform check and no issues were noted.A reproducibility test was performed on the reported sample.The results were noted to be discrepant.A reproducibility test was performed on a different patient sample.The results were satisfactory.Accuracy and precision tests for the assay were performed with acceptable results.Qc for the troponin t assay was performed with acceptable results.No instrument issues were identified.The instrument was cleared for use.The investigation is ongoing.

Manufacturer Narrative

The calibration signals were within the specified ranges.A general reagent problem can be excluded because the provided qc, calibration data and precision tests were within specifications.The serum sample was collected in a sarstedt, monovette, serum gel 13 x 75 mm tube.The customer used rack adapters.The clotting time for the sample was requested but not provided.The sample was centrifuged for 10 minutes at 4000 rpm.The centrifugation conditions did not meet the recommendations of the tube supplier.The high and low results obtained also point to a sample quality issue.After service, no further issues were reported by the customer.Based on the information provided a general reagent or instrument problem can be excluded.

• Brand Name: ELECSYS TROPONIN T HS STAT
• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 13823842
• MDR Text Key: 294389403
• Report Number: 1823260-2022-00759
• Device Sequence Number: 1
• Product Code: MMI
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K201441
• 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: 04/28/2022

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: 07/31/2022
• Device Catalogue Number: 09315349190
• Device Lot Number: 523669
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/18/2022
• Initial Date FDA Received: 03/19/2022
• Supplement Dates Manufacturer Received: 04/04/2022
• Supplement Dates FDA Received: 04/28/2022
• 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: DIPYRONE; KETOPROFEN
• Patient Sex: Male