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

Model Number E411 RACK

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/02/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer obtained a questionable low result for one patient sample using the elecsys total psa immunoassay (tpsa) on a cobas e 411 immunoassay analyzer.All results are in units of ng/ml, and all were released outside of the laboratory.One of the results was flagged; however, it is unclear which result was accompanied by a data flag.The initial result was 0.The physician questioned the result and the sample was repeated.The repeat result was 11 ng/ml, which was deemed correct.No adverse event occurred.The tpsa reagent lot number is 170634; the expiration date was not provided.The customer spoke with her "chemistry person" and stated that the sample was still cold when it was analyzed.The "chemistry person" told the customer that the reason for the discrepant results was due to the sample still being cold when it was analyzed.The customer questioned this reasoning since she had run other samples directly from the refrigerator at the same time that did not give results of 0.The customer contact center agent explained that the sample should be allowed to warm up before analysis.The customer contact center agent explained that other causes of getting a falsely low result could include bubbles in the sample or reagent, or using a sample tube with a diameter smaller than the required specifications.The field service representative completed an assay performance check which passed.Investigation activities are ongoing.

Manufacturer Narrative

The following is a correction to previously reported information: clarification was received that the initial result was accompanied by a data flag.The initial result was 0 with a data flag.The following is additional information: calibration signals were low in (b)(6) 2017.Quality controls were in range.A general product issue was excluded.A specific root cause could not be identified.Additional information for further investigation was requested but was not provided.The issue is most likely a non-reproducible low discrepant result.Possible root causes for the issue may be bubbles or foam on the sample surface; lack of use of rack adapters with 13 mm sample tubes; sample tube not placed straight prior to sampling; and/or improper sample preparation or insufficient maintenance.

• 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: 6581961
• MDR Text Key: 75690295
• Report Number: 1823260-2017-01072
• 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: 06/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2017
• 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
• Date Manufacturer Received: 05/02/2017
• 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