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

Model Number E601

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/13/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer stated the qc results for elecsys testosterone ii assay had been running high.They tested a different lot of qc material and the results were still high.Precision testing with qc material was performed and failed.A patient correlation was then performed with previously tested patient samples.One example was provided.The initial result on (b)(6) 2017 was 190.1 ng/dl and the repeat result on (b)(6) 2017 was 276.3 ng/dl.They customer did not know which result was correct and stated questionable results may have been reported outside the laboratory for up to 20 patient samples.Information concerning if any patient was adversely affected was requested but it was unknown.The reagent lot number was 19105304 with an expiration date of 28-feb-2018.The field application specialist took some of the customer's reagents, calibrators, and qc material to another site for troubleshooting.The field service representative found the sipper nozzle needed to be replaced.He replaced the sipper nozzle and the tubing.He ran performance testing which passed.Further investigation found the issue with the sipper nozzle was the cause of the event.A query was performed and found no past or new issues of this nature on any like instruments for the last 12 months at this site.

• 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: 6907272
• MDR Text Key: 89574161
• Report Number: 1823260-2017-02164
• Device Sequence Number: 0
• Product Code: CDZ
• 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: Medical Technologist
• Type of Report: Initial
• Report Date: 10/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2017
• 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
• Date Manufacturer Received: 09/14/2017
• 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: 56 YR