MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 6000 E 601 MODULE; IMMUNOCHEMISTRY ANALYZER

Model Number E601

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/28/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Unique identifier (udi)#: (b)(4).

Event Description

The customer stated that they did an evaluation of patient samples tested for the elecsys troponin t hs stat assay (tnthsst) on two cobas 6000 e 601 module (e601) analyzers.This evaluation was done to determine the number of result outliers in patient samples tested between (b)(6) 2018 and (b)(6) 2018.The customer provided data for a total of 454 patient samples tested in duplicate for tnthsst.Of the 454 patient samples, 5 had erroneous results measured on one e601 analyzer that were reported outside of the laboratory.The initial values from the samples were reported outside of the laboratory.The repeat results were not reported outside of the laboratory.The customer did not know which values were correct.The samples were processed on a modular pre-analytics system.Primary sample tubes were centrifuged and aliquoted into cups.The first sample initially resulted as 9.07 ng/l and repeated as 19.4 ng/l.The second sample initially resulted as 23.68 ng/l on (b)(6) 2018 and repeated as 8.5 ng/l.The third sample initially resulted as 85.29 ng/l on (b)(6) 2018 and repeated as 38.75 ng/l.The fourth sample initially resulted as 214.5 ng/l on (b)(6) 2018 and repeated as 359.6 ng/l.The fifth sample initially resulted as 3 ng/l on (b)(6) 2018 and repeated as 7.33 ng/l.No adverse events were alleged to have occurred with the patients.The tnthsst reagent lot number and expiration date were asked for, but not provided.

Manufacturer Narrative

The tnthsst reagent lot number was 267654.

Manufacturer Narrative

The customer provided data for approximately 1978 additional patient samples tested on both e601 analyzers.Of these, two additional patient samples had erroneous tnthsst results.The erroneous results were reported outside of the laboratory.The first sample initially resulted with a tnthsst value of 10.15 ng/l on (b)(6) 2018, which repeated as 12.47 ng/l.The second sample initially resulted with a tnthsst value of 9.09 ng/l on (b)(6) 2018, which repeated as 12.13 ng/l.No adverse events were alleged to have occurred with these additional patients.

Manufacturer Narrative

The application specialist performed precision testing for tnt-hs using quality control materials and the results were acceptable.Analyzer performance testing was completed and was ok.It was determined the analyzer was performing normally.

Manufacturer Narrative

The customer had an additional event with erroneous results for tnthsst.The initial tnthsst value was 137.5 ng/ml.The result was automatically repeated from the same aliquot cup and generated a result of 4.52 ng/l.The aliquot and primary tube were repeated again and all results were around 3 ng/l.The erroneous results were not reported outside of the laboratory.There is no allegation of an adverse event.The investigation is ongoing.

Manufacturer Narrative

The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: COBAS 6000 E 601 MODULE
• Type of Device: IMMUNOCHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7661189
• MDR Text Key: 113396516
• Report Number: 1823260-2018-02192
• Device Sequence Number: 1
• Product Code: JJE
• Combination Product (y/n): N
• PMA/PMN Number: K060373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E601
• Device Catalogue Number: 04745922001
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1