MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 E 602 MODULE; IMMUNOCHEMISTRY ANALYZER

Model Number E602

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/19/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This event occurred in (b)(6).

Event Description

The customer complained of questionable elecsys vitamin b12 ii immunoassay, elecsys estradiol iii assay, and elecsys ft4 ii assay results on a cobas 8000 e 602 module.Of the data provided, there was a discrepant ft4 ii result for 1 patient sample.The initial ft4 ii result was 1.77 and the repeat result was 16.99.No units of measure were measured.There was no allegation of an adverse event.No erroneous results were reported outside of the laboratory.The ft4 ii reagent lot number was 288197.The expiration date was not provided.

Manufacturer Narrative

The customer stated that on 06-jul-2018 they received questionable ft4 ii results for an additional 2 patient samples.The data provided for the additional samples was not a reportable event.

Manufacturer Narrative

A bubble was created in the sample tube causing the false low results.The investigation determined this bubble was due to improper sample preparation.The investigation did not identify a product problem.

• Brand Name: COBAS 8000 E 602 MODULE
• Type of Device: IMMUNOCHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7663975
• MDR Text Key: 113397119
• Report Number: 1823260-2018-02205
• Device Sequence Number: 1
• Product Code: JJE
• Combination Product (y/n): N
• PMA/PMN Number: K100853
• 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
• Report Date: 10/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E602
• Device Catalogue Number: 05990378001
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1