MAUDE Adverse Event Report: ROCHE DIAGNOSTICS 9180 ELECTROLYTE ANALYZER

Model Number ISE 9180

Device Problem High Test Results (2457)

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

Event Date 10/05/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.

Event Description

There was an allegation of questionable ise indirect gen 2 results from the electrolyte analyzer 9180.One example was provided of an initial sodium result of 145 mmol/l and repeat results of 149 mmol/l and 160 mmol/l.The questionable result was not reported outside of the laboratory.The electrode lot number was 21590947.The expiration date was 28-feb-2022.

Manufacturer Narrative

The investigation did not identify a product problem.The cause of the event could not be determined.The provided calibration and qc data were acceptable.The involved electrodes were past the acceptable in-use time based on the installation date.

• Brand Name: 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15657794
• MDR Text Key: 306992029
• Report Number: 1823260-2022-03312
• Device Sequence Number: 1
• Product Code: JFP
• Combination Product (y/n): N
• Reporter Country Code: EC
• PMA/PMN Number: K961458
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2022
• 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
• Date Manufacturer Received: 12/22/2022
• 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