MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 COBAS ISE MODULE (DOUBLE); CLINICAL CHEMISTRY ANALYZER

Model Number COBAS 8000 ISE

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 10/12/2017

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).(b)(4).

Event Description

The customer complained of ongoing calibration and quality control (qc) issues on a cobas 8000 ise module particularly with sodium (na).The customer stated that erroneous patient results have now occurred.The customer provided an example of an initial na result of 172 (unit of measure not provided) that when repeated was 155.No erroneous results were reported outside of the laboratory.There was no allegation that an adverse event occurred.The na electrode lot number and expiration date were not provided.

Manufacturer Narrative

The initial erroneous na results were an approximation.On 02-nov-2017 the customer provided the actual results and description of event from (b)(6) 2017 that caused them to look at na results more closely.The initial na result was 174.8 mmol/l which was above the normal range.This result was released and repeat testing was requested.The repeat result was 155 mmol/l which was above the normal range.The result of 155 mmol/l was released and repeat testing was requested.The 2nd repeat result was 151.3 mmol/l which was above the normal range.The result of 151.3 mmol/l was released from the laboratory.The field service engineer (fse) visited the customer site and performed decontamination procedures.The fse stripped both ise measuring systems and rebuilt with new electrodes (including the reference electrode) and replaced the pinch tubings.The instrument was primed and 30 ise checks were performed.The sample probe was readjusted.The dilution bath was cleaned and nozzles were adjusted.The customer ran calibration and quality controls which were acceptable.There have been no further issues since the service visit on (b)(6) 2017.A specific root cause was not identified.Possible root causes may be related to an electrode issue, a human factor, an ise/reference flow problem or contamination.The service actions taken by the fse are seen as the appropriate general maintenance actions.The instrument is working according to specifications.

• Brand Name: COBAS 8000 COBAS ISE MODULE (DOUBLE)
• 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: 6993487
• MDR Text Key: 91928155
• Report Number: 1823260-2017-02499
• Device Sequence Number: 0
• Product Code: JGS
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K100853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: COBAS 8000 ISE
• Device Catalogue Number: ASKU
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2017
• 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