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

Catalog Number ASKU

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/10/2015

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer reported that they received an erroneous result for one patient sample tested for total prostate-specific antigen (tpsa).The sample initially resulted as 0.024 ng/ml and this value was reported outside of the laboratory.The patient complained about the result, so the sample was repeated.The sample was repeated on (b)(6) 2015, resulting as 9.58 ng/ml accompanied by a data flag.The patient was not adversely affected.The tpsa reagent lot number was 181675, with an expiration date of 01/30/2016.It was determined that liquid flow cleaning of the instrument was pending and the last time it was performed was on 09/25/2015.The laboratory staff was informed to follow the recommended timelines for maintenance of the instrument.The sample probe cleaning was also not being performed as recommended for part of daily maintenance.A specific root cause could not be determined.The issue is most likely related to a fibrin clot or gel particle.A general issue with the reagent or analyzer can be excluded.

• Brand Name: COBAS E411
• 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; ibarak 312-8 504; JA 312-8504
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 5192285
• MDR Text Key: 29985302
• Report Number: 1823260-2015-04426
• 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: Health Professional
• Type of Report: Initial
• Report Date: 10/30/2015

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: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Initial Date Manufacturer Received: 10/12/2015
• Initial Date FDA Received: 10/30/2015
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 060 YR