MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ROCHE 9180 ELECTROLYTE ANALYZER

Model Number ISE 9180

Device Problem Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/05/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The customer's qc was acceptable.The field service engineer confirmed the customer's analyzer was ok and didn't find any abnormalities.The investigation is ongoing.

Event Description

The initial reporter received discrepant results for one patient sample tested for potassium on the roche 9180 electrolyte analyzer.The patient's potassium results were not reported outside the laboratory.The customer performed repeat testing with the patient's sample for confirmation.At 12:40 p.M., the patient's potassium result was 5.4 mmol/l with a data flag.At 12:42 p.M., the patient's potassium result was 5.6 mmol/l with a data flag.At 12:59 p.M., the patient's potassium result was 5.3 mmol/l with a data flag.At 13:01 p.M., the patient's potassium result was 4.5 mmol/l.At 13:02 p.M., the patient's potassium result was 5.3 mmol/l with a data flag.The customer performed an additional potassium measurement, and the patient's potassium result was 5.1 with a data flag.The time of measurement was requested but not provided.The potassium electrode lot number was 21500348 with an expiration date requested but not provided.The potassium electrode had an install by date of(b)(6) 2020, and the electrode was installed on (b)(6) 2020.

Manufacturer Narrative

The potassium electrode lot number was 21500348 with an expiration date of 31-jul-2020.The investigation confirmed the customer performed the recommended maintenance procedures on the system.The investigation requested the affected snappak, reference electrode, potassium electrode, and needle unit for further investigation.The customer was unable to send the parts in for an investigation as the parts remained in use.The customer has not reported any further issues.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: 10921053
• MDR Text Key: 244115809
• Report Number: 1823260-2020-03036
• 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: 02/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2020
• 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: 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1