MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 6000 E601 MODULE; IMMUNOCHEMISTRY ANALYZER

Model Number E601

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/23/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer complained of questionable results for one blood sample while testing for elecsys ferritin (ferritin).It was stated that they received a result of 0.515 ng/ml without any flags on an aliquoted tube on cell 1.They reran the sample and got 695.1 ng/ml without any flags on the same aliquoted sample on the same cell.They reran the primary tube on cell 2 and obtained a value of 728 ng/ml.All of these results were from the same analyzer.They originally reported the 0.515 ng/ml result but they "caught it almost immediately and reran it and reported the 695.1 ng/ml.They believed the 695.1 value to be the correct result." there was no adverse event.The reagent is lot number 18714303 with an expiration date of 10/31/2016.The field service representative visit found no cause for the results.A general reagent issue cannot be seen based on the provided quality control data.The instrument was checked and successful performance testing was done.A specific root cause could not be identified.Additional information for further investigation was requested but was not provided.

• Brand Name: COBAS 6000 E601 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: 5648409
• MDR Text Key: 45050192
• Report Number: 1823260-2016-00626
• Device Sequence Number: 0
• Product Code: JMG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E601
• Device Catalogue Number: 04745922001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2016
• Initial Date FDA Received: 05/11/2016
• 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: 60