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 07/14/2023

Event Type  malfunction  

Manufacturer Narrative

The serial number of the cobas 6000 e 601 module is 2534-02.The field service engineer performed liquid flow cleaning (lfc).After this, the quality controls were acceptable.The investigation is ongoing.

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with the elecsys troponin t hs assay on a cobas 6000 e 601 module.The sample initially resulted in a troponin t hs value of < 5 ng/l, accompanied by a data flag and repeated as 17 ng/l.

Manufacturer Narrative

The customer reported that the issue re-occurred.Precipitates at the sipper were found and an abnormal sipper movement alarm was observed.After performing three times, liquid flow cleaning the issue has been resolved.The investigation could not identify a product problem.The cause of the event could not be determined.

• 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 17396484
• MDR Text Key: 319866814
• Report Number: 1823260-2023-02491
• Device Sequence Number: 1
• Product Code: MMI
• Combination Product (y/n): N
• Reporter Country Code: NO
• 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: 08/29/2023

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: 09315349190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/14/2023
• Initial Date FDA Received: 07/26/2023
• Supplement Dates Manufacturer Received: 08/08/2023
• Supplement Dates FDA Received: 08/29/2023
• 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