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

Model Number E411 RACK

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 03/08/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer received questionable troponin t hs results for three patient samples.Sample 1 results were 0.099 ug/l with a data flag, 0.003 ug/l with a data flag, and 0.003 ug/l with a data flag.Sample 2 ((b)(6) 2017) results were 0.070 ug/l with a data flag, 0.055 ug/l with a data flag, 0.054 ug/l with a data flag, and 0.05 ug/l with a data flag.Sample 3 ((b)(6) 2017) results were 0.026 ug/l with a data flag, 0.003 ug/l with a data flag, and 0.003 ug/l with a data flag.No erroneous results were reported outside the laboratory.There was no allegation of an adverse event.The reagent lot number was 13869601 with an expiration date of 07/31/2017.

Manufacturer Narrative

A specific root cause could not be identified.Additional information for further investigation was requested but was not provided.For sample 1, it was possible there was a bubble on a system reagent as the instrument alarm trace indicated a bottle changeover occurred immediately before the event.The provided calibration, qc and alarm data did not indicate any other issues.Sample 2 was from a (b)(6) year old male.The patient was post vascular surgery.Sample 3 was from a (b)(6) year old female.The patient had diabetes.

• 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: 6747305
• MDR Text Key: 81190495
• Report Number: 1823260-2017-01542
• Device Sequence Number: 0
• Product Code: MMI
• Combination Product (y/n): N
• Reporter Country Code: MU
• 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: 08/18/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E411 RACK
• Device Catalogue Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2017
• 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: 24 YR