MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS E411 RACK SYSTEM; IMMUNOCHEMISTRY ANALYZER

Catalog Number 04775201001

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/27/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer questioned low results for 20 patients tested for cancer antigen 125 (ca 125 ii) after changing a reagent pack.Results were provided for 2 patients.Of the data provided, the ca 125 ii results for 1 patient were erroneous and reported outside of the laboratory.The initial ca 125 ii result was 12.0 u/ml.After performing a reagent pack calibration, the repeat result was 189 u/ml.The repeat result was considered to be correct.Both results were reported to the patient's physician.No adverse event occurred.The ca 125 ii reagent lot number was 181804.The expiration date was not provided.It was noted that the customer performed a lot calibration on (b)(6) 2015 and the signals were high.After the calibration on (b)(6) 2015, the customer performed reagent pack calibration several times but did not perform a lot calibration.A reagent pack calibration was performed on (b)(6) 2015 and the values were higher than expected but acceptable.A specific root cause could not be identified.Additional information for further investigation was requested but was not provided.A general reagent and instrument issue can be excluded.The most likely root cause of the erroneous results was the calibration that was performed on (b)(6) 2015.After the calibration that was performed on (b)(6) 2015, the customer did not observe any more questionable low results.

• Brand Name: COBAS E411 RACK SYSTEM
• Type of Device: IMMUNOCHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• 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: 5220125
• MDR Text Key: 31002385
• Report Number: 1823260-2015-04525
• Device Sequence Number: 0
• Product Code: LTK
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 11/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2015
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 04775201001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Date Manufacturer Received: 10/27/2015
• 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