MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 6000 E 601 MODULE; IMMUNOCHEMISTRY ANALYZER

Model Number E601

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/20/2017

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer stated that they received an erroneous result for one patient sample tested for the elecsys total psa immunoassay (tpsa) on a cobas 6000 e 601 module (e601).The erroneous result was reported outside of the laboratory to the patient.The sample initially resulted as 9.36 ng/ml.The result was doubted based on the patient's previous results.The sample was repeated, resulting as 0.75 ng/ml.The sample was also repeated twice on (b)(6) 2017, each time resulting as 0.75 ng/ml.Repeat testing for another test parameter run on the sample was ok.No adverse events were alleged to have occurred with the patient.The tpsa reagent lot number and expiration date were asked for, but not provided.The customer repeated 5 previous patient samples and all results were ok.The sample run just prior to the complained sample did not have an increased tpsa result.The customer noted that there were sample volume alarms for other tubes and these were confirmed to have low sample volume.There was no hemolysis of the complained sample and the volume was correct.Controls run before and after the complained sample were acceptable.

Manufacturer Narrative

A specific root cause could not be identified based on the available information.Discrepant high results are typically caused by carryover.The most likely root cause is contamination of the analyzer or of the sample itself.The customer has performed repeatability checks and no issues were observed.The issue did not occur again.A sample related issue is most likely.Based on the available data a specific root cause could not be identified.

• Brand Name: COBAS 6000 E 601 MODULE
• 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: 7009603
• MDR Text Key: 92609143
• Report Number: 1823260-2017-02555
• Device Sequence Number: 0
• Product Code: LTJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K060373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/20/2017

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: E601
• Device Catalogue Number: 04745922001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2017
• Initial Date FDA Received: 11/08/2017
• Supplement Dates Manufacturer Received: 10/23/2017
• Supplement Dates FDA Received: 11/20/2017
• 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