MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ROCHE 9180 ELECTROLYTE ANALYZER

Model Number ISE 9180

Device Problem Non Reproducible Results (4029)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/04/2022

Event Type  malfunction  

Manufacturer Narrative

The customer stated the calibration were ok, but qc sometimes failed.The reagents were replaced on (b)(6) 2022.The electrodes were replaced at the end of (b)(6) 2021.The customer was advised to clean ports and probes and also mix internal fluid of the electrodes.Due to the lack of data that was provided, further investigation could not be performed.The investigation did not identify a product problem.The cause of the event could not be determined.

Event Description

There was an allegation of questionable li+ electrode results for 1 patient sample and questionable na+ electrode results for 1 patient sample on a roche 9180 electrolyte analyzer.Patient 1: the initial lithium result was 0.7 mmol/l and the repeated result was 0.5 mmol/l.Patient 2: the initial sodium result was 139 mmol/l and the repeated result was 147 mmol/l.It is unknown if the results were reported outside of the laboratory.The electrode lot numbers and expiration dates were requested, but not provided.

• Brand Name: ROCHE 9180 ELECTROLYTE ANALYZER
• Type of Device: ELECTROLYTE ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE INSTRUMENT CENTER AG TEGIMENTA; forrenstrasse; na; rotkreuz 6343 ; SZ 6343
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 13620296
• MDR Text Key: 292726177
• Report Number: 1823260-2022-00539
• Device Sequence Number: 1
• Product Code: JFP
• UDI-Device Identifier: 04015630031832
• UDI-Public: 04015630031832
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K961458
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/04/2022
• Initial Date FDA Received: 02/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1