MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS INTEGRA 400 PLUS ANALYZER; CLINICAL CHEMISTRY ANALYZER

Model Number	I400+
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter complained of discrepant results for 2 patient samples tested for iron2 iron gen.2 (iron2) on a cobas integra 400 plus.Patient 1 initial result was 0.46 ug/dl.The repeat result was 1.5 ug/dl.The sample was repeated by an unknown method in another laboratory with a result of 18.40 ug/dl.Patient 2 initial result was 9.10 ug/dl.The repeat result was 9.96 ug/dl.The sample was repeated by an unknown method in another laboratory with a result of 25.30 ug/dl no questionable results were reported outside of the laboratory.The iron2 reagent lot number was 60819101 with an expiration date of 31 jan 2023.
Additional Manufacturer Narrative
Instrument maintenance is up to date.Sample clot messages occurred on the same day and around the time of these results.No other assays were affected.The field application specialist (fas) checked the sample tubes, de-installed the reagent application, and then reinstalled it, configured special washes, and performed calibration and qc.The fas performed repeatability testing with qc material and the variability was high.The next day the customer also performed repeatability testing with qc material and the results were approximately half of those from the day before.The field service engineer visited the customer site on (b)(6) 2022 and decontaminated the rinse station and the internal water tank.The detection cables of both pipetting needles were replaced.A new reagent cassette was loaded, calibrated, and qc was performed.Qc was acceptable.Repeatability testing was performed on (b)(6) 2022 and (b)(6) 2022 with acceptable results.Repeatability testing performed on (b)(6) 2022 was not within specification.The investigation is ongoing.
Additional Manufacturer Narrative
Discrepant iron2 results were provided for an additional patient sample.On (b)(6)2022 the initial result at the customer site was 5.09 ug/dl.The sample was repeated in another laboratory using an unspecified cobas instrument with a result of 14.50 ug/dl the iron2 reagent lot number used at this time was 64195701.The expiration date was not provided.
Additional Manufacturer Narrative
Discrepant iron2 results were provided for an additional 2 patient samples.On (b)(6) 2022 the initial result at the customer site was 4.52 ug/dl.The sample was repeated in another laboratory and the result was 16.40 ug/dl.On (b)(6) 2023 the initial result at the customer site was 0.4 ug/l.The repeat result was 0.8 ug/dl.The iron2 reagent lot number used at this time was 657869.The expiration date was not provided.Section b6 was updated.
Additional Manufacturer Narrative
Calibration and qc data were reviewed and were acceptable.The field service engineer (fse) revisited the customer site on 17-feb-2023 to check the instrument and no issues were identified.A review of the customer's database related to maintenance actions that should be completed was performed.It was found that some maintenance actions that should be done by the customer were either not performed (the 'done' button was pressed instead of 'perform') or the actions were not performed with the help of the service action software.One of the maintenance actions to be performed is "clean probes and splash guard." product labeling states "you must perform a number of service actions to ensure that your analyzer runs reliably." a general reagent issue can be ruled out as calibration and qc were acceptable.The investigation did not identify a product problem.The specific cause of the event could not be determined, however, the issue is consistent with insufficient maintenance actions at the customer site.

• Brand Name: COBAS INTEGRA 400 PLUS ANALYZER
• Common Device Name: CLINICAL CHEMISTRY 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: 15742548
• Report Number: 1823260-2022-03505
• Device Sequence Number: 17910902
• Product Code: JJE
• UDI-Device Identifier: 04015630918904
• UDI-Public: 04015630918904
• Combination Product (Y/N): N
• Initial Reporter Country: RO
• PMA/510(K) Number: K951595
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/08/2023

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
• Operator of Device: Health Professional
• Device Model Number: I400+
• Device Catalogue Number: 03245233001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2022
• Supplement Date Received by Manufacturer: 12/22/2022; 01/09/2023; 02/20/2023
• Initial Report FDA Received Date: 11/07/2022
• Supplement Report FDA Received Date: 01/05/2023; 01/25/2023; 03/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown