MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 6000 C (501) MODULE; CLINICAL CHEMISTRY ANALYZER

Model Number C501

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/18/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer experienced an ongoing issue with questionable ise indirect gen.2 sodium results.Data was provided for two patient samples.Patient 1 initial result was 146 mmol/l with a data flag and the repeat result was 140 mmol/l.Patient 2 initial result was 119 mmol/l and the repeat result was 140 mmol/l.The initial results were reported outside of the laboratory.The repeat results were believed to be correct.The patients were not adversely affected.The electrode lot number and expiration date were requested but were not provided.The customer received calibration alarms, replaced all the ise reagents and performed an ise check which was acceptable.The customer ran qc which was acceptable.The field service representative found there was a misadjusted sample probe and rinse nozzle which he adjusted.He checked the fluidic and pneumatic systems and ran calibration, qc, and precision testing with no errors and all values within specification.

Manufacturer Narrative

A specific root cause could not be identified.Additional information for further investigation was requested but was not provided.The most likely causes include mis-sampling of the patient material or calibration errors.A query was performed for this type of complaint and no abnormal trend identified during the past 90 days.

• Brand Name: COBAS 6000 C (501) MODULE
• Type of Device: CLINICAL CHEMISTRY 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: 6914652
• MDR Text Key: 89649375
• Report Number: 1823260-2017-02200
• Device Sequence Number: 0
• Product Code: JGS
• 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,Followup
• Report Date: 11/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C501
• Device Catalogue Number: 04745914001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 58 YR