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

Model Number E411 DISK

Device Problem High Test Results (2457)

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

Event Date 09/21/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer received a questionable high elecsys ft4 ii assay result for one patient sample.The initial result was > 7.77 ng/dl and the repeat result was 1.32 ng/dl.The erroneous result was not reported outside the laboratory.There was no allegation of an adverse event.The reagent lot number was 18042901 with an expiration date of 30-sep-2017.The calibration and qc results at the site had been acceptable.

Manufacturer Narrative

A specific root cause could not be determined.From the analysis of the calibration and qc data, a general reagent issue could most likely be excluded.As low calibration signals were noted; this could point to an issue with the overall handling and storage conditions of the reagents.Typical causes for this type of event include bubbles/foam on the surfaces of the reagents, microclots/fibrin filaments in the sample, or the mixer not within specifications.

• 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: 6939855
• MDR Text Key: 90309904
• Report Number: 1823260-2017-02264
• Device Sequence Number: 0
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: TC
• 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: 11/07/2017
• 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: E411 DISK
• Device Catalogue Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/24/2017
• Initial Date FDA Received: 10/11/2017
• Supplement Dates Manufacturer Received: 09/24/2017
• Supplement Dates FDA Received: 11/07/2017
• 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
• Patient Age: 19 YR