MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS E 801 ANALYTICAL UNIT; IMMUNOCHEMISTRY ANALYZER

Catalog Number	08454345001
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter questioned results for qc and patient samples tested for elecsys folate iii (folate iii) on a cobas e 801 analytical unit.Of the data provided for 20 patient samples, the results for 6 patient samples were discrepant.The customer ran the patient samples on the e801 analyzer in question (analyzer 5) and 2 other analyzers (analyzer 2 and analyzer 3).Patient 1 result from analyzer 5 was 8.65 ng/ml.The repeat result from analyzer 2 was 5.51 ng/ml.The repeat result from analyzer 3 was 5.26 ng/ml.Patient 2 result from analyzer 5 was 2.18 ng/ml.The repeat result from analyzer 2 was 3.36 ng/ml.The repeat result from analyzer 3 was 3.28 ng/ml.Patient 3 result from analyzer 5 was 3.52 ng/ml.The repeat result from analyzer 2 was 5.13 ng/ml.The repeat result from analyzer 3 was 4.53 ng/ml.Patient 4 result from analyzer 5 was 3.91 ng/ml.The repeat result from analyzer 2 was 5.24 ng/ml.The repeat result from analyzer 3 was 4.31 ng/ml.Patient 5 result from analyzer 5 was 3.77 ng/ml.The repeat result from analyzer 2 was 5.01 ng/ml.The repeat result from analyzer 3 was 4.1 ng/ml.On (b)(6) 2023 the sample for patient 1 was repeated analyzer 5 with a result of 8.29 ng/ml.The sample was repeated on analyzer 3 with a result of 5.09 ng/ml.On (b)(6) 2023 patient 6 result from analyzer 5 was 8.62 ng/ml.The sample was repeated on anlayzer 3 with a result of 4.91 ng/ml.
Additional Manufacturer Narrative
The folate iii reagent lot number was 728047 with an expiration date of 31-oct-2024.The field service engineer (fse) found a bent prewash sipper nozzle and replaced it.Instrument performance testing was acceptable.The customer had no further issues after the service visit.The investigation determined the event was consistent with a maintenance issue.

• Brand Name: COBAS E 801 ANALYTICAL UNIT
• Common Device Name: IMMUNOCHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18443930
• Report Number: 1823260-2024-00028
• Device Sequence Number: 7965272
• Product Code: JJE
• UDI-Device Identifier: 07613336158456
• UDI-Public: 07613336158456
• Combination Product (Y/N): Y
• Initial Reporter Country: UK
• PMA/510(K) Number: K060373
• 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
• Report Date (Section B): 01/04/2024

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 Catalogue Number: 08454345001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/14/2023
• Initial Report FDA Received Date: 01/04/2024
• 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