MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS E 411 ANALYZER (RACK SYSTEM); IMMUNOCHEMISTRY ANALYZER

Model Number	E411 RACK
Medical Device Problem Codes	Incorrect Measurement (1383); Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable elecsys probnp ii ver.2.1 immunoassay results for 1 patient sample on a cobas e 411 immunoassay analyzer.The initial probnp result was 36.00 pg/ml with flag.The result was reported outside of the laboratory.The physician questioned the result and the sample was repeated.The customer replaced the reagent pack prior to repeating the sample as there were only a few tests left on the initial reagent pack.The sample was repeated 3 times and the results were 3318 pg/ml, 3335 pg/ml, and 3305 pg/ml.The repeat results were deemed correct.Both probnp reagent packs' lot numbers were 64177200 and the expiration dates are 30-jun-2023.
Additional Manufacturer Narrative
The investigation is ongoing.
Additional Manufacturer Narrative
The field service engineer (fse) did not find a cause for the event.Calibration was last performed on (b)(6) 2023 with acceptable results.Qc was not initially within the customer's established ranges, however, after repeating it was acceptable.The qc results appeared to be low.This is an indication of a reagent or instrument performance issue.The alarm trace did not contain a conspicuous event.It was found that the customer's centrifugation time may be too short and the speed may be too slow.Based on the data provided, the investigation did not identify a product problem.The root cause of the event could not be determined.

• Brand Name: COBAS E 411 ANALYZER (RACK SYSTEM)
• 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: 16307580
• Report Number: 1823260-2023-00364
• Device Sequence Number: 6792235
• Product Code: JJE
• UDI-Device Identifier: 07613336191569
• UDI-Public: 07613336191569
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K961481
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2023

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: E411 RACK
• Device Catalogue Number: 04775201001
• 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: 01/11/2023
• Supplement Date Received by Manufacturer: 03/20/2023
• Initial Report FDA Received Date: 02/06/2023
• Supplement Report FDA Received Date: 04/12/2023
• 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 Age: 44 YR
• Patient Sex: Male
• Patient Weight: 65 KG