MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS E 411 IMMUNOASSAY ANALYZER; IMMUNOCHEMISTRY ANALYZER

Model Number E411 DISK

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/05/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer received questionable elecsys total psa immunoassay results for four patient samples from (b)(6) 2016.Of the data provided, only the results for one patient sample that occurred on (b)(6) 2016 were discrepant.The patient had a history of total psa results at approximately 8 ng/ml.On (b)(6) 2016, a sample from the patient was tested and the result was 0.061 ng/ml (<0.1 ng/ml).The sample was repeated and the result was 0.080 ng/ml (<0.1ng/ml).The results were reported to the doctor.On (b)(6) 2016, the doctor questioned the results and the same sample was thawed and repeated with a result of 7.70 ng/ml with a data flag.This result was believed to be correct.On (b)(6) 2016, the patient gave a new specimen and the result for that sample was 9.24 ng/ml.The patient was not adversely affected.The reagent lot number was 13598600 with an expiration date of 05/31/2017.The field service representative visited the site and collected data for further investigation.

Manufacturer Narrative

A specific root cause could not be identified.Possible root causes include foam or air bubbles on the sample surface, a missing tube adapter, foam or air bubbles on the reagent pack, foam or air bubbles on the system reagent, or old pinch tubes being used on the system.Based on the provided calibration and qc data, a general reagent or system issue was not indicated.

• Brand Name: COBAS E 411 IMMUNOASSAY ANALYZER
• 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: 5904538
• MDR Text Key: 53045173
• Report Number: 1823260-2016-01277
• 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: 09/07/2016

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/17/2016
• Initial Date FDA Received: 08/25/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/07/2016
• 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