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

Catalog Number 04745922001

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 05/28/2015

Event Type  malfunction  

Event Description

The customer received questionable cortisol results for one patient while performing a method correlation for 18 patients between the cortisol and cortisol ii reagents.The unit of measure was not provided.First testing: cortisol 100.4 cortisol ii 38.5 second testing: cortisol 148.7 cortisol ii 74.62 third testing: cortisol 161.2 cortisol ii 96.86 information concerning if any erroneous result was reported outside the laboratory or if the patient was adversely affected was requested, but was not provided.The cortisol reagent lot number was 185360.The expiration date was requested, but was not provided.The cortisol ii reagent lot number and expiration date were requested, but were not provided.

Manufacturer Narrative

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

Manufacturer Narrative

Additional information was received that medwatch field (date received by manufacturer) was actually (b)(4) 2015.The cortisol reagent lot was actually 185380.The cortisol ii reagent lot number was 185360.Samples from the patient were submitted for investigation and the customer's results were confirmed.A specific root cause could not be identified.Additional information for further investigation was requested but was not provided.

Manufacturer Narrative

Additional information was provided that the results were generated for a method comparison only.No erroneous results were reported outside the laboratory and no patients were adversely affected.

Manufacturer Narrative

A general reagent issue was not suspected based on the provided qc data and the confirmation of the results for the samples when tested during investigation.Differences in the results between the two reagents may be due to the different antibodies used and the standardization.Although the results for a single sample differ between the reagents, the interpretation is comparable.

• Brand Name: COBAS 6000 E601 MODULE
• Type of Device: IMMUNOCHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• 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: 4857055
• MDR Text Key: 5851796
• Report Number: 1823260-2015-03680
• Device Sequence Number: 0
• Product Code: NHG
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K060373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,foreign,health profe
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/21/2015

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 Catalogue Number: 04745922001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Initial Date Manufacturer Received: 05/28/2015
• Initial Date FDA Received: 06/19/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 06/23/2015; 06/25/2015; 07/08/2015
• 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
• Patient Sequence Number: 1
• Treatment: GALVUS; AMIODARORE; AMLODIPINE; CUSTOR; KAROLEGIC; SYNACTHENE
• Patient Age: 082 YR