MAUDE Adverse Event Report: ROCHE DIAGNOSTICS 9180 ELECTROLYTE ANALYZER

Model Number ISE 9180

Device Problem Low Test Results (2458)

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

Event Date 05/11/2022

Event Type  malfunction  

Event Description

The initial reporter stated they received discrepant results for four patient samples tested with electrode, ise lithium on a 9180 electrolyte analyzer.The samples were initially tested on (b)(6) 2022 and the initial lithium values were reported outside of the laboratory and were questioned by the doctor.The customer replaced the system reagent that day and ran controls.On (b)(6) 2022, the samples were repeated and the customer stated that all controls recovered within range.The first sample initially resulted in a lithium value of 0.16 mmol/l and repeated as 0.6 mmol/l.The second sample initially resulted in a lithium value of 0.11 mmol/l and repeated as 0.49 mmol/l.The third sample initially resulted in a lithium value of < 0.1 mmol/l and repeated as 0.24 mmol/l.The fourth sample initially resulted in a lithium value of < 0.1 mmol/l and repeated as 0.38 mmol/l.The lot number of the lithium electrode was 21520847, with an expiration date of 09-sep-2022.

Manufacturer Narrative

The field service engineer found bubbles in the reference electrode tubing.The lithium electrode was changed and the bubbles in the reference electrode were removed by priming the system.The samples were repeated on (b)(6) 2022 after this action.The first sample repeated with a lithium value of 0.67 mmol/l.The second sample repeated with a lithium value of 0.51 mmol/l.The third sample was repeated twice, with lithium values of 0.36 mmol/l and 0.40 mmol/l.The fourth sample repeated with a lithium value of 0.47 mmol/l.Precision studies were also performed with the affected samples, with lithium results as follows: sample 1: 0.71 mmol/l, 0.71 mmol/l, 0.71 mmol/l, 0.68 mmol/l, 0.70 mmol/l, 0.68 mmol/l.Sample 2: 0.68 mmol/l, 0.62 mmol/l, 0.61 mmol/l, 0.70 mmol/l, 0.67 mmol/l, 0.68 mmol/l, 0.69 mmol/l, 0.67 mmol/l, 0.67 mmol/l, 0.67 mmol/l.Sample 3: 0.45 mmol/l, 0.41 mmol/l, 0.43 mmol/l.Sample 4: 0.52 mmol/l, 0.53 mmol/l, 0.54 mmol/l.On (b)(6) 2022, the engineer found a bubble inside the reference electrode and suspected there was leakage from the reference electrode connector.The full facility name was provided as "(b)(6)".

Manufacturer Narrative

Three levels of control were within range on (b)(6) 2022.The first level of control was run at a later time on the same day and was rejected.Calibration performed on (b)(6) 2022 was within limits.The electrodes, analyzer, and system reagent were provided for investigation.The reference electrode housing had an install before date (b)(6) 2020.If installed on this date, the electrode was valid until (b)(6) 2021 based on an in-use time of 52 weeks.Based on photographs, air bubbles were observed in the reference system tubes.In the received reference housing and tubes, the tubes and housing were disconnected.The housing and tubes showed no damage, neither at the tubes or connector.The reference electrode had an install before date of (b)(6) 2020 and was installed on (b)(6) 2021.No damage to the electrode was observed.The lithium electrode had an install before date of (b)(6) 2022 and was installed on (b)(6) 2022.With a 13 weeks in-use time, the electrode was valid until (b)(6) 2022.It was observed that the electrode had enough inner solution and no visible damage.The system reagent pack received had an expiration date of 13-jan-2024.The pack showed no leakage or damage.The reagent pack was installed on a retention instrument.Calibrations and controls were ok for the lithium parameter as well as for other parameters.15 control measurements were performed with each control level and only one measurement for the level 1 control was 30% different.Based on the specification for the lithium electrode, bias and repeatability were within specification.The discrepancies observed by the customer could not be reproduced.Despite observing bubbles in the tubes during retention testing, no leakage was observed at reference electrode housing connectors or the tubes.All measurements were within specifications except for the one outlier.The reference electrode housing, reference electrode, and lithium electrode certificates of analysis showed no irregularities at the time of production.The investigation could not identify a product problem.The 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 14574819
• MDR Text Key: 293264378
• Report Number: 1823260-2022-01586
• Device Sequence Number: 1
• Product Code: JFP
• UDI-Device Identifier: 04015630031832
• UDI-Public: 04015630031832
• Combination Product (y/n): N
• Reporter Country Code: MC
• 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: 09/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2022
• 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: 08/29/2022
• 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