MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 6000 C501 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 10/05/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer stated that they received erroneous results for one patient sample tested for ise indirect na, ci for gen.2 (sodium, chloride) on a cobas 6000 c (501) module - c501.No erroneous results were reported outside of the laboratory.The customer stated that this was the only sample they had an issue with.The sample initially resulted with a sodium value of 125 mmol/l and repeated as 140 mmol/l.The chloride result was initially 116.6 mmol/l and repeated as 98.5 mmol/l.The repeat results were believed to be correct.The patient was not adversely affected.The sodium and chloride electrode lot numbers and expiration dates were asked for, but not provided.Calibration and quality controls performed both before and after the event were successful.The field service engineer could not determine a cause.He replaced the sipper nozzle, pinch tube, and sipper tube.He cleaned the ise area, performed and air purge, performed a reagent prime and ran ise checks 15 times.He performed precision studies.The customer ran calibration and quality controls.

Manufacturer Narrative

All electrodes used on the analyzer were installed on (b)(6) 2017.The lot number of the sodium electrode was b9091 and the lot number of the chloride electrode was r5082.No other assays were affected in the event.The affected sample was initially run in the primary tube, which was processed on a modular pre-analytics system.The customer pulled the primary tube and manually loaded it on the analyzer for repeat testing.A specific root cause could not be determined based on the provided information.Additional information required for the investigation was requested, but not provided.Possible root causes include air in the sample channel, leakage of current coming from the waste, or an old and/or expired reference electrode.No further issues were reported after the service actions.

• Brand Name: COBAS 6000 C501 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: 6971019
• MDR Text Key: 90845013
• Report Number: 1823260-2017-02406
• 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: Medical Technologist
• Type of Report: Initial,Followup
• Report Date: 11/02/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C501
• Device Catalogue Number: 05860636001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2017
• 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: 69 YR