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

Model Number E411 DISK

Device Problem Low Test Results (2458)

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

Event Date 06/25/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer received a questionable low elecsys afp assay result for one patient sample.The initial result was 4.00 iu/ml and was reported outside the laboratory.The patient had a sacrococcygeal soft tissue mass between gluteal muscles (yolk sac tumor).After an operation, the mass was determined to be malignant and the laboratory was informed.The same sample was repeated 10 times on (b)(6) 2017 and the result was consistently >1000 iu/ml with a data flag.There was no allegation of an adverse event.The reagent lot number was 17674700 with an expiration date of 10/31/2017.The current date set on the analyzer was backdated for an unknown reason.Review of the provided calibration data did not find any issues and confirmed it was acceptable.

Manufacturer Narrative

A specific root cause could not be identified.Possible causes include improper pre-analytic handling or bubbles or foam on the reagent surface.Typical causes for this type of event include issue with the sample quality or insufficient maintenance of the analyzer.Based on the information provided, a general product problem was excluded.

• 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: 6770153
• MDR Text Key: 83311720
• Report Number: 1823260-2017-01621
• Device Sequence Number: 0
• Product Code: CDZ
• Combination Product (y/n): N
• Reporter Country Code: IR
• PMA/PMN Number: K961481
• 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: 09/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E411 DISK
• Device Catalogue Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2017
• 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: 23 MO