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

Catalog Number 04660307190

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/15/2018

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi)#: (b)(4).

Event Description

Between (b)(6) 2018 and (b)(6) 2018, the customer stated that they received erroneous results for 14 samples from 13 patients tested for the elecsys troponin t stat assay (tnthsst) on the e411 analyzer.The operator of the analyzer noticed the pipette tips were falling off of the probe.The field service engineer found that the probe was loose because the probe cover was not closed and latched.He made adjustments.Pipette tips were found in the reagent pack that was in use for testing.Refer to the attachment for all patient data.All erroneous initial results were reported outside of the laboratory.The samples were repeated on a cobas 6000 e 601 module (e601) and the repeat results were believed to be correct.All patients received non-invasive procedures based on the erroneous tnthsst results.Refer to the attachment for information related to all patient interventions.No adverse events were alleged to have occurred with the patients.The e411 analyzer serial number was (b)(4).The tnthsst reagent lot number was 273497.The reagent expiration date was asked for, but not provided.The field service engineer determined the issue to be related to the reagent pack as things were working after the pack change.He ran calibration and controls with a new pack.He also ran comparison studies between the e411 and e601 analyzers.All results were within specifications.He clarified that he did not know if reagent tips were actually inside the pack that was changed.

Manufacturer Narrative

The alarm trace indicated several liquid level detection alarms on the date of the event.Additional information was requested for investigation, but was unable to be provided by the customer.The investigation was unable to find a definitive root cause.

• Brand Name: ELECSYS TROPONIN T STAT ASSAY
• Type of Device: IMMUNOASSAY METHOD, TROPONIN SUBUNIT
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7489913
• MDR Text Key: 108156120
• Report Number: 1823260-2018-01392
• Device Sequence Number: 1
• Product Code: MMI
• Combination Product (y/n): N
• PMA/PMN Number: K051752
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 08/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04660307190
• Device Lot Number: 273497
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 36 YR