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

Model Number	E801
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qc was acceptable on the day of the event.The alarm trace showed several sample clot, sample short, and sample foam detection errors between (b)(6) and (b)(6) 2022.Based on the available data, a general reagent issue could be excluded.The investigation did not identify a product problem.The root cause of the event could not be determined.
Event or Problem Description
There was an allegation of questionable elecsys vitamin d assay results for 1 patient sample on a cobas e 801 analytical unit.On (b)(6) 2022, the initial vitamin d result was 100 ng/ml with flag.On (b)(6) 2022, the sample was repeated twice and the results were 11.2 ng/ml and 20.8 ng/ml.The initial result was not reported outside of the laboratory.The reagent lot is 601999 and the expiration date is 28-feb-2023.

• 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; na; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16052740
• Report Number: 1823260-2022-04188
• Device Sequence Number: 12326702
• Product Code: JJE
• UDI-Device Identifier: 04015630940127
• UDI-Public: 04015630940127
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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): 12/27/2022

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: E801
• Device Catalogue Number: 08454345001
• 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: 12/07/2022
• Initial Report FDA Received Date: 12/27/2022
• 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