MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 6000 E 601 MODULE; IMMUNOCHEMISTRY ANALYZER

Model Number E601

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/29/2017

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi)#: (b)(4).

Event Description

The customer received a questionable elecsys ferritin result for one patient sample.The initial result was 1.02 ng/ml and the repeat result was 39.94 ng/ml.The initial result was reported outside the laboratory.The repeat result was believed to be correct.The patient was not adversely affected.The reagent lot number was 20990805 with an expiration date of 5/31/2018.The field service representative flushed the reagent probe, checked and cleaned the bead mixer and sipper probe, and visually inspected measuring cell.The customer ran calibration and qc.No abnormal trends were identified for this issue.The customer has had no other complaints of this nature on a like analyzer in the past 12 months.

• Brand Name: COBAS 6000 E 601 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: 6728024
• MDR Text Key: 80789470
• Report Number: 1823260-2017-01506
• 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: 07/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E601
• Device Catalogue Number: 04745922001
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2017
• 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: 6 YR