MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 E 602 MODULE; IMMUNOCHEMISTRY ANALYZER

Model Number E602

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/15/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer received questionable low elecsys ferritin results for one patient sample that had been aliquoted from the primary sample tube at another site.The initial result was 13 ng/ml and was reported outside the laboratory.The doctor called and questioned the result as the patient has a history of ferritin results in the mid-2000 range.The result from a previous sample on (b)(6) 2016 was 2344 ng/ml.Between the time the initial result was generated and when the repeat testing was performed, the customer migrated the ferritin assay to another cobas e602 analyzer because they were balancing their tests across the analyzers.All repeat testing was performed on another cobas e602 analyzer.The customer repeated the sample and the result was 2000 ng/ml with a data flag.After automatic dilution, the result was 2319 ng/ml.The sample from (b)(6) 2016 was then retested and the result was 2000 ng/ml with a data flag.After automatic dilution, the result was 2371 ng/ml.The customer contacted the doctor with the updated result and posted a corrected report.The patient was not adversely affected.The reagent lot number was 13307004 with an expiration date of 6/30/2017.The field service representative found there possibly a sample issue.He flushed the sample and reagent pathways and checked the sample aspiration.He verified the calibration and qc data.Based on the information provided, a specific root cause could not be identified.Additional information for further investigation was requested but was not provided.A general reagent issue could not be detected.General root causes for this type of issue include issues with sample quality or insufficient maintenance.

• Brand Name: COBAS 8000 E 602 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: 6134878
• MDR Text Key: 61148285
• Report Number: 1823260-2016-01869
• Device Sequence Number: 0
• Product Code: JMG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100853
• 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: 11/30/2016

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: E602
• Device Catalogue Number: 05990378001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2016
• Initial Date FDA Received: 11/30/2016
• 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