MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS E411 SYSTEM; IMMUNOCHEMISTRY ANALYZER

Catalog Number ASKU

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/06/2014

Event Type  malfunction  

Event Description

The customer alleged they received questionable vitamin b12 results on their e411 analyzer.The customer provided data for two patients with discrepant results.The first patient's initial vitamin b12 result was 44.55 pg/ml accompanied by a data flag and it was reported outside the laboratory.The sample was repeated on this e411 analyzer and the results were 71.43 pg/ml accompanied by a data flag and 71.63 pg/ml accompanied by a data flag.The patient's sample was then tested on another e411 analyzer and the result was 136.6 pg/ml.The second patient was a (b)(6) old male.The initial vitamin b12 result was 55.55 pg/ml accompanied by a data flag and it was reported outside the laboratory.The sample was repeated on this e411 analyzer and the result was 76.45 pg/ml accompanied by a data flag.The sample was then tested on the other e411 analyzer and the result was 122.3 pg/ml.The patients were not adversely affected by this event.The vitamin b12 reagent lot number was 174159.The expiration date was requested but not provided.

Manufacturer Narrative

This event occurred in (b)(6).The specific part number involved in this event was requested but not provided.

Manufacturer Narrative

A definitive root cause could not be determined with the information provided.Additional details were requested but not provided.The calibration and quality control data were within range.However, it was noted the customer was not following the proper calibrator handling requirements in the calibrator product labeling.

• Brand Name: COBAS E411 SYSTEM
• 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- 8504; JA 312-8504
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 3824397
• MDR Text Key: 4391611
• Report Number: 1823260-2014-03581
• Device Sequence Number: 1
• Product Code: CDD
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K961481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Date Manufacturer Received: 05/07/2014
• 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
• Patient Age: 023 YR