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

Catalog Number	08454345001
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with elecsys prolactin ii on a cobas e 801 analytical unit.The sample initially resulted in a prolactin value of 870 uiu/ml.The sample was treated with polyethylene glycol (peg) and repeated.The result was higher than the initial value.No specific value was provided.Since the peg treated value was higher, the sample was repeated two additional times on (b)(6) 2023, resulting in prolactin values of 1430 uiu/ml and 1416 uiu/ml.
Additional Manufacturer Narrative
The serial number of the e801 analyzer is (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
Calibration data was within expectations.Quality controls recovered within range.A reagent issue was not present since controls before the event were within range.Upon review of the alarm trace, no relevant alarms were observed.The field service engineer checked and cleaned dirty reagent probes, sipper nozzles, and pre-wash nozzles.The analyzer was often giving degasser low-pressure errors, so the degasser pump was replaced.The investigation determined the service actions resolved the issue.The operator is required to clean all probes and nozzles daily.

• 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 46250-0457
• MDR Report Key: 18334878
• Report Number: 1823260-2023-04025
• Device Sequence Number: 12705897
• Product Code: JJE
• UDI-Device Identifier: 07613336158456
• UDI-Public: 07613336158456
• Combination Product (Y/N): Y
• Initial Reporter Country: RO
• PMA/510(K) Number: K060373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/16/2024
• 2 Devices were Involved in the Event: 1 2

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
• Device Lot Number: 716142
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/04/2023
• Supplement Date Received by Manufacturer: 01/04/2024; 01/16/2024
• Initial Report FDA Received Date: 12/15/2023
• Supplement Report FDA Received Date: 01/05/2024; 01/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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