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

Model Number E411 RACK

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/26/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer experienced an issue over several days where the elecsys free psa immunoassay would be ordered in the cobas e 411 immunoassay analyzer software for patient samples and qc material where the test had not been requested and the result for free psa was identical for all patient samples.The field service representative could not find a cause.Operational and mechanical checks were acceptable.The customer powered down and rebooted the analyzer multiple times.The customer's laboratory information system (lis) was also restarted.The instrument was then running as expected and the problem seemed to be resolved.On (b)(6) 2018, the customer repeated all of the patient samples.Two examples were provided.Patient 1 original result was 39.98 ng/ml and the repeat result was 1.87 ng/ml.Patient 2 original result was 39.98 ng/ml and the repeat result was 0.488 ng/ml.No erroneous results were reported outside of the laboratory.The repeat results were believed to be correct.No patients were adversely affected.The free psa reagent lot number was 243142.The expiration date was requested but was not provided.The investigation confirmed the software issue which has been corrected in a new software version.

• 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: 7273535
• MDR Text Key: 100451245
• Report Number: 1823260-2018-00453
• 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: Medical Technologist
• Type of Report: Initial
• Report Date: 02/15/2018

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?: Yes
• Initial Date Manufacturer Received: 01/30/2018
• Initial Date FDA Received: 02/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1