MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 E 602 MODULE; IMMUNOCHEMISTRY ANALYZER

Model Number E602

Device Problem Low Test Results (2458)

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

Event Date 09/13/2017

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).(b)(4).

Event Description

The customer complained of a low erroneous result for 1 patient sample tested for elecsys ft4 ii assay (ft4 ii) on cobas 8000 e 602 module.The erroneous result was not reported outside of the laboratory.The initial ft4 ii result was 57.34 pmol/l.The customer repeated the sample 3 times with results of 30.95 pmol/l, 52.49 pmol/l and 55.30 pmol/l.The result of 57.34 pmol/l was reported outside of the laboratory.Approximately 2 hours later the sample was repeated 4 more times with results of 53.43 pmol/l, 54.81 pmol/l, 57.37 pmol/l and 54.11 pmol/l.There was no allegation that an adverse event occurred.The ft4 ii reagent lot number was 21545500.The expiration date was not provided.Since quality control results were acceptable, a general reagent issue is not suspected.During a review of the alarm trace reset cleancell and reset procell alarms were observed.This indicates the customer pressed the respective reset buttons and replaced the cleancell and procell solutions.This would not have impacted the issue the customer is complaining about.Based on the multiple repeat testing performed at the customer site, the result of approximately 50 pmol/l is most likely correct.A common root cause for low results with the assay the customer is complaining about is related to pipetting an insufficient sample amount.This could be caused by micro-clots/fibrin filament or gel clots in the sample.Micro-clots or gel clots could have affected the sample volume being pipetted or the micro-clots or gel clots could have been transferred to the measuring cell and affected the correct amount of electrochemiluminescence (ecl) counts.

Manufacturer Narrative

A specific root cause was not identified.Based on the information available, a general reagent issue can be excluded.There may be issues with pre-analytical sample preparation conditions at the customer site.

• Brand Name: COBAS 8000 E 602 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: 6921515
• MDR Text Key: 89945814
• Report Number: 1823260-2017-02209
• Device Sequence Number: 0
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K100853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/24/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E602
• Device Catalogue Number: 05990378001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2017
• Initial Date FDA Received: 10/06/2017
• Supplement Dates Manufacturer Received: 09/15/2017
• Supplement Dates FDA Received: 10/24/2017
• 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
• Patient Age: 20 YR