MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ROCHE 9180 ELECTROLYTE ANALYZER

Model Number ISE 9180

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/20/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter stated they received discrepant results for one patient sample tested for sodium, potassium, and calcium on a roche 9180 electrolyte analyzer.The sample initially resulted with a sodium value of 109 mmol/l accompanied by a data flag, which repeated as 118 mmol/l accompanied by a data flag.The sample initially resulted with a potassium value of 5.3 mmol/l accompanied by a data flag, which repeated as 3.2 mmol/l accompanied by a data flag.The sample initially resulted with a calcium value of 0.96 mmol/l accompanied by a data flag, which repeated as 1.16 mmol/l.The sodium, potassium, and chloride electrode lot numbers and expiration dates were requested, but not provided.

Manufacturer Narrative

The customer stated the electrodes were expired.The electrodes were replaced around (b)(6) 2020 and the customer states the instrument has worked ok.One level of control failed after the complained sample measurements.The investigation determined the issue is consistent with the use of expired electrodes.

• 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: 9813123
• MDR Text Key: 216114264
• Report Number: 1823260-2020-00700
• 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: 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2020
• 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: 02/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1