MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ROCHE 9180 ELECTROLYTE ANALYZER

Model Number ISE 9180

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/30/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The field service engineer (fse) visited the customer site and inspected the instrument: removed the tubing harness, electrodes, needle and wash port.The instrument surfaces were thoroughly cleaned.The fse noted evidence of leakage as crystals were observed underneath the chassis.The crystal buildup was cleaned up from the external surfaces.The main board was removed and the back of valves were inspected.Evidence of leakage was observed and some valves were rusty.The fse cleaned the internal crystal buildup and replaced the vent and valve line.Preventive maintenance was performed.The instrument initially calibrated for sodium and chloride but k+ failed.The fse performed additional cleaning cycles and k+ calibrated ok afterwards.Three levels of qc were acceptable.The fse ran qc again and k+ was out of range high for level 3.The instrument was calibrated again and qc was acceptable.The instrument was put back in service with a new electrode.The customer has not had any further issues since the service visit.

Event Description

The initial reporter complained of discrepant results for 1 patient sample tested for potassium (k+) on an electrolyte analyzer ise 9180 instrument compared to an abl 90 flex instrument.The result from the ise 9180 instrument was 3.5 mmol/l.The same sample was run on an abl 90 flex instrument and the result was 5.2 mmol/l.There was no allegation that an adverse event occurred.The k+ electrode lot number was 21584549.The expiration date was not provided.The customer stated qc had been performed daily and had passed.After this event, qc was run and the results were low for k+.The customer changed the fluid pack and qc was back within the acceptable range.After making this change, the customer compared 2 patient samples from the ise 9180 to the abl 90 flex instrument and the results were comparable to one another.On (b)(6) 2019 the customer had issues with qc results for k+ not passing again and the k+ parameter could not be calibrated at all.

Manufacturer Narrative

The customer returned electrodes and reagent packs for investigation.The customer¿s observation could not be reproduced.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ROCHE 9180 ELECTROLYTE ANALYZER
• Type of Device: ELECTROLYTE ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 8620976
• MDR Text Key: 145425331
• Report Number: 1823260-2019-01869
• Device Sequence Number: 1
• Product Code: JFP
• Combination Product (y/n): N
• PMA/PMN Number: K961458
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ISE 9180
• Device Catalogue Number: 03157334001
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1