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 11/16/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer stated that they received erroneous results for two patient samples tested for the elecsys ca 15-3 ii assay (ca 15-3) and the elecsys total psa immunoassay (tpsa) on a cobas 6000 e 601 module (e601).The erroneous results were reported outside of the laboratory.It was stated that the low results did not fit the clinical picture of the patients.The first sample initially resulted as > 100 ng/ml for tpsa on (b)(6) 2016.The sample was diluted 1:10 and repeated, resulting as 0.53 ng/ml.The second sample, from a (b)(6) female born on (b)(6) 1955, initially resulted as 1.00 u/ml accompanied by a data flag for ca 15-3 on (b)(6) 2017.The sample was repeated, resulting as 24.51 u/ml for ca 15-3 on (b)(6) 2017.The patients were not adversely affected.The ca 15-3 reagent lot number was 161228.The tpsa reagent lot number was 135984.The expiration dates for these reagents were asked for, but not provided.No crystals were found in the system reagent cups and the mixer was found to be within specifications.Calibrations were within acceptable limits and controls were within specifications.Samples were tested from primary tubes which were processed on a cobas p612 pre-analytics system.

Manufacturer Narrative

A specific root cause could not be determined based on the provided information.Additional information required for the investigation was requested but not provided.The investigation found no other cases for the same incident within the last six months.Possible root causes for this event may be insufficient electromagnetic interference compliance, sample quality, improper handling of the reagent or system reagents, insufficient maintenance, or contamination of the environment with the analyte.

• Brand Name: COBAS 6000 E 601 MODULE
• Type of Device: IMMUNOCHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; na; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 6321967
• MDR Text Key: 67280690
• Report Number: 1823260-2017-00270
• Device Sequence Number: 0
• Product Code: MOI
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K060373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E601
• Device Catalogue Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2017
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1