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

Model Number E411 DISK

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/16/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

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 0.715 ng/ml and this value was reported outside of the laboratory.The physician asked for the sample to be repeated since the patient had a prostatectomy in (b)(6) 2014.The sample was repeated in the original tube, resulting as < 0.007 ng/ml.The sample was also repeated in a sample cup, resulting as <0.007 ng/ml.The repeat result was believed to be correct.The patient was not adversely affected.The tpsa reagent lot number was 18677101, with an expiration date of 07/31/2016.The field service representative was not able to duplicate the issue.He inspected the fluidics system of the analyzer and no issues were seen.He replaced the measuring cell as a precaution.He performed a system volume check, a high voltage adjustment to the photomultiplier tube, a blank cell calibration, and performance testing.All results passed.

Manufacturer Narrative

A field application specialist checked basic processes at the site, such as sample handling and analyzer maintenance.The field application specialist checked the calibrations performed on the analyzer and noted that calibration signals for tpsa were "bouncing all over the place".A specific root cause could not be determined based on the provided information.There was no indication of a general issue with the reagent.No further issues were noted to have occurred after the measuring cell was changed.It is likely that the issue was caused by an "old" measuring cell.

• Brand Name: COBAS E411 DISK 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: 5332466
• MDR Text Key: 34593357
• Report Number: 1823260-2015-06141
• Device Sequence Number: 0
• Product Code: LTJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K961481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/19/2016

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 DISK
• Device Catalogue Number: 4775279001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2015
• Initial Date FDA Received: 12/29/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/19/2016
• 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
• Patient Age: 66 YR