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 10/15/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.

Event Description

There was an allegation of questionable ca2 calcium gen.2 results for 1 patient sample on an avl 9180 electrolyte analyzer.The initial ca2 result was 0.5 mmol/l.The repeat result on another avl analyzer was 0.38 mmol/l.The initial result was reported outside of the laboratory.The repeat result was deemed correct.The calcium electrode lot number is 21522247.The expiration was requested but not provided.

Manufacturer Narrative

The investigation found that the customer was using non-approved quality controls and had not performed daily maintenance on the day of the event.Per product labeling, "use of consumables that were not produced by roche, including but not limited to electrodes, calibration and cleaning solutions, qc-material and related accessories, may result in malfunction of the analyzer and may render the warranty null and void." per product labeling, "before performing the first sample of the day, the 9180 electrolyte analyzer needs to undergo a simple cleaning and conditioning procedure that ensures the analyzer will perform properly." the field service engineer found a defective solenoid valve.No other information was provided.The investigation did not identify a product problem.The root cause of the event could not be determined.

• 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: 15763788
• MDR Text Key: 307266228
• Report Number: 1823260-2022-03565
• Device Sequence Number: 1
• Product Code: JFP
• UDI-Device Identifier: 04015630031832
• UDI-Public: 04015630031832
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 01/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2022
• 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: 12/23/2022
• 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