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

Catalog Number 04775279001

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/17/2014

Event Type  malfunction  

Event Description

The customer alleged they received a questionable total prostate- specific antigen (tpsa) result for one patient on their e411 analyzer.The patient's initial tpsa result was 0.261 ng/ml and it was reported outside the laboratory.The initial tpsa result was queried by the consultant.Due to the clinical history, the result was expected to be far lower.The previous results for the patient averaged at 0.002 ng/ml.On (b)(6) 2014, the patient had a fresh sample tested and the tpsa result was 0.004 ng/ml.On (b)(6) 2014, the original sample was repeated and the tpsa result was 0.002 ng/ml accompanied by a data flag.The patient was recalled for treatment, but the customer repeated the tpsa test first.The patient was not adversely affected by this event.The tpsa reagent lot number was 04641655 and the expiration date provided was 11/2014.The customer replaced the pinch tubing and performed a liquid flow cleaning.

Manufacturer Narrative

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

• Brand Name: COBAS E411 DISK 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: 3733069
• MDR Text Key: 4322282
• Report Number: 1823260-2014-02451
• Device Sequence Number: 1
• Product Code: LTJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 04/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04775279001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Initial Date Manufacturer Received: 03/24/2014
• Initial Date FDA Received: 04/08/2014
• 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: 067 YR