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

Model Number E602

Device Problem High Test Results (2457)

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

Event Date 09/12/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer complained of an erroneous high result for 1 patient sample tested 3 times for elecsys ft4 ii assay (ft4 ii) on a cobas 8000 e 602 module.The erroneous result was not reported outside of the laboratory.The customer submitted the sample for investigation and the results from an e602 module used at the investigation site and a cobas e 411 immunoassay analyzer used at the investigation site were erroneous compared to the 1 high result the customer received.The ft4 ii results generated during the investigation compared well to the other two ft4 ii results from the customer¿s e602 module.Refer to attached data for the patient results.There was no allegation that an adverse event occurred.The ft4 ii reagent lot number and expiration date used at the customer site were not provided.The e602 module serial number used at the investigation site was (b)(4).The e411 analyzer serial number was 0600-12.The ft4 ii reagent lot number used at the investigation site was 215455 with an expiration date of 31-mar-2018.A specific root cause was not identified.Additional information was requested for investigation but was not provided.Except for the high result of 2.36 ng/dl generated at the customer site, all other values generated at the customer site and the investigation site were within the normal reference ranges of the assay.Based on the information available, a general reagent issue is not likely.Possible root causes for the high result may be related to a sample specific issue such as pre-analytic preparation or to reagent specific issue such as the presence of foam or bubbles on the reagent surface.

• 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: 6939763
• MDR Text Key: 90308871
• Report Number: 1823260-2017-02262
• Device Sequence Number: 0
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 10/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E602
• Device Catalogue Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2017
• 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