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	12/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On 24-jan-2023 the field service engineer (fse) checked various parts of the instrument, replaced the crej2 cassette, and performed reproducibility testing on iron2, crp4, and gluc3 with acceptable results.The analyzer was confirmed to be working with no issues.The investigation is ongoing.Device evaluated by mfr: na.
Event or Problem Description
The initial reporter complained of discrepant results for 1 patient sample tested for gluc3 glucose hk gen.3 (gluc3) and iron2 iron gen.2 (iron2), 1 patient sample tested for crej2 creatinine jaffé gen.2 (crej2) and 1 patient sample tested for tina-quant c-reactive protein iv (crp4) on a cobas integra 400 plus.Patient 1 initial gluc3 result was 500 mg/dl.The repeat result was 85 mg/dl.The sample was repeated by the abbott method with a result of 79 mg/dl.Patient 1 initial iron2 result was 5 ug/dl.The repeat result was 82 ug/dl.The questionable results for patient 1 did not match their historical results.On (b)(6) 2023 patient 2 initial crej2 result was 80 mg/dl.The repeat result by the abbott method was 9 mg/dl.No results were reported.The results did not correspond to the patient¿s clinical picture.On (b)(6) 2023 patient 3 initial crp4 result was 9.89 mg/l.The repeat result was 81.08 mg/l.This result was reported outside of the laboratory as it matched the patient¿s historical results.No questionable results were reported outside of the laboratory.The gluc3 reagent lot number was 60356401 with an expiration date of 31-mar-2023.The iron2 reagent lot number was 65786901 with an expiration date of 31-aug-2023.The crej2 reagent lot number was 62098401 with an expiration date of 30-nov-2023.The crp4 reagent lot number was 64528601 with an expiration date of 31-jun-2023.
Additional Manufacturer Narrative
Section b3, the date of the event was updated.On (b)(6) 2023 the field service engineer (fse) visited the customer site and performed reproducibility testing with acceptable results.The customer has had no further issues.Based on the information provided, the investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 16286750
• Report Number: 1823260-2023-00327
• Device Sequence Number: 6728832
• Product Code: JJE
• UDI-Device Identifier: 04015630918904
• UDI-Public: 04015630918904
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 03/17/2023

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: 01/13/2023
• Supplement Date Received by Manufacturer: 03/06/2023
• Initial Report FDA Received Date: 02/02/2023
• Supplement Report FDA Received Date: 03/17/2023
• 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