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

Catalog Number 04745922001

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/25/2014

Event Type  malfunction  

Event Description

The customer received a questionable antibody to hepatitis c virus (anti-hcv) result for one patient.The result from the cobas e 601 analyzer was 0.459 coi (non-reactive).On (b)(6) 2014, the result from the abbott architect i1000 analyzer was 2.93 s/co(positive).The result of 0.459 coi was reported outside the laboratory.The patient was not adversely affected.The anti-hcv reagent lot number was 175153 with an expiration date of 06/29/2014.

Manufacturer Narrative

The investigation could not determine a specific root cause.Additional information for further investigation was requested, but was not provided.It was also noted that no patient sample could be provided for further investigation.

Manufacturer Narrative

This event occurred in (b)(6).

• Brand Name: COBAS 6000 E601 MODULE
• 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: 3622930
• MDR Text Key: 4134710
• Report Number: 1823260-2014-00902
• Device Sequence Number: 1
• Product Code: MZP
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K060373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04745922001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Date Manufacturer Received: 01/28/2014
• 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
• Patient Sequence Number: 1
• Patient Age: 036 YR