MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 6000 E601 MODULE; IMMUNOCHEMISTRY ANALYZER

Model Number E601

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/13/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer questioned high results for 2 oncology patients tested for ferritin.The customer had switched from the ilab 650 turbidimetric method to the e601 analyzer using the electrochemiluminescence method in (b)(6) 2015 and noticed a difference in the results for these 2 patients in (b)(6) 2016.Based on the data provided, the results for 1 patient were erroneous and reported outside of the laboratory with a note that the method had changed.The initial ferritin result from the e601 analyzer was >2000 ng/ml with a data flag.After a manual dilution of 1:50 the repeat result was 32.77 ng/ml.The calculated result was 1638 ng/ml.This result was reported outside of the laboratory.Since the customer is questioning the ferritin results from the e601 analyzer, they are testing samples using the turbidimetric method on a c501 analyzer.The initial sample was repeated on a different day on the e601 analyzer and the result was 4030 ng/ml.This sample was also repeated on the c501 analyzer and the result was 3569 ng/ml.The customer thinks the results from the c501 analyzer are correct and now believes the results from the e601 analyzer since they are comparable to the c501.The last result from a different sample on the ilab 650 was 962 ng/ml.No adverse event occurred.The ferritin reagent lot number was 187143.The expiration date was not provided.

Manufacturer Narrative

A specific root cause could not be identified.Additional information for further investigation was requested but was not provided.A general ferritin reagent issue can be excluded since quality controls were acceptable.

• Brand Name: COBAS 6000 E601 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: 5413062
• MDR Text Key: 37619505
• Report Number: 1823260-2016-00110
• Device Sequence Number: 0
• Product Code: JMG
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2016
• Initial Date FDA Received: 02/05/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/18/2016
• 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
• Patient Age: 74 YR