MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS INTEGRA 400 PLUS W/O ISE; 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	09/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable iron2 iron gen.2 results for 2 patient samples on a cobas integra 400 plus module.On (b)(6) 2022, patient 1 had an initial iron result of 5.82 ug/dl.The first repeat result was 7.84 ug/dl and the second repeat result was 42.98 ug/dl.The sample was sent to another lab and the iron result was 13.19 ug/dl.On (b)(6) 2022, patient 2 had an initial iron result of 61.74 ug/dl.The first repeat result was 0.31 ug/dl.On (b)(6) 2022, the sample was repeated a second time and the result was 12.83 ug/dl.No questionable results were reported outside of the laboratory.The iron reagent lot is 65786901 and the expiration date is 31-aug-2023.
Additional Manufacturer Narrative
Iron calibration performed on 29-sep-2022 was acceptable.Calibration was not performed again until 18-oct-2022.The investigation found that there were several postponed calibration messages in the data log.The message log showed that controls performed on 17-oct-2022 were acceptable but calculated using a postponed calibration.The alarm trace showed several clot detection and no fluid detection alarms.The investigation did not identify a product problem.The root cause of the event could not be determined.

• Brand Name: COBAS INTEGRA 400 PLUS W/O ISE
• 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: 15833179
• Report Number: 1823260-2022-03693
• Device Sequence Number: 5775686
• Product Code: JJE
• UDI-Device Identifier: 04015630918904
• UDI-Public: 04015630918904
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• 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
• Report Date (Section B): 12/20/2022

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: 04922859001
• 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: 10/27/2022
• Supplement Date Received by Manufacturer: 11/30/2022
• Initial Report FDA Received Date: 11/21/2022
• Supplement Report FDA Received Date: 12/20/2022
• 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