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

Model Number E411 RACK

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/25/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer complained of erroneous results for 1 patient tested for total (free + complexed) psa - prostate-specific antigen (tpsa) - total psa.The erroneous results were reported outside of the laboratory.The total psa result from the first day was 1 ng/ml.The second day the total psa result was 74 ng/ml.It is not clear if these results are from the same sample or different samples.No adverse event occurred.The total psa reagent lot number was not provided.

Manufacturer Narrative

A specific root cause could not be identified.Additional information for further investigation was requested but was not provided.

• Brand Name: COBAS E411 RACK SYSTEM
• 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: 5510374
• MDR Text Key: 40668740
• Report Number: 1823260-2016-00328
• Device Sequence Number: 0
• Product Code: LTJ
• 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,u
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/12/2016

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: E411 RACK
• Device Catalogue Number: 04775201001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/25/2016
• Initial Date FDA Received: 03/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/13/2016
• 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