MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ROCHE 9180 ELECTROLYTE ANALYZER

Model Number ISE 9180

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/03/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Phone number was provided as (b)(6).

Event Description

The initial reporter stated they received discrepant results for one patient sample tested for calcium ion on the roche 9180 electrolyte analyzer.The analyzer is used to test samples from pre-dialysis and post-dialysis blood patients.The pre-dialysis samples perform well on the analyzer, but post dialysis samples have been showing lower values on the instrument.The patient sample resulted with a calcium ion value of 0.64 mg/dl on the complained 9180 system.The sample was repeated on a second 9180 analyzer, resulting with a value of 2.49 mg/dl.The 2.49 mg/dl value was considered to be correct.The calcium ion electrode was replaced and preventive maintenance was performed on the analyzer.The sample was repeated after these actions and resulted with a calcium ion value of 0.27 mg/dl.The sample was repeated on the second 9180 analyzer, resulting with a value of 2.47 mg/dl.The low values were not considered compatible with post-dialysis results.The lot number and expiration date of the calcium ion electrode was requested, but not provided.

Manufacturer Narrative

The calcium electrode that was in use during the time of the event was installed in march 2020, but had an install before date of (b)(6) 2018, therefore it was installed more than one year after the install before date.The customer inserted the electrodes from one instrument to the other, however the same values were released in each instrument, which suggested an interference only in one instrument.Moreover, these discrepancies are observed only for post-dialysis samples.Instrument serial number (b)(6) was assembled and released in 2006 and therefore it cannot be excluded that some corrosion could have built over the time near the electrode contact points.The temperature set for both instruments was checked and it was noticed there was a small difference between them.All electrodes were replaced and the temperature was adjusted for instrument serial number (b)(6).The instrument performed ok after these actions.An interference only in instrument serial number (b)(6) could be explained by a different unit configuration applied on serial number (b)(6) the calcium result of 0.64 mmol/l (2.56 mg/dl) would reflect the same value obtained on the second 9180 analyzer.The most likely root cause for the issue is a different unit configuration for the calcium parameter on the analyzers or the service code activation on one analyzer.

• 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: 10449857
• MDR Text Key: 204427832
• Report Number: 1823260-2020-02099
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2020
• 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: 08/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1