MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS VITAMIN B12 II; RADIOASSAY, VITAMIN B12

Catalog Number	07028121190
Medical Device Problem Codes	Low Test Results (2458); Output Problem (3005); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The calibration data for the e 801 was acceptable.The qcs for the e 801 were within the +/-3 standard deviation (sd) range from (b)(6) 2024.The alarm trace showed several clot detection errors.It was found that the customer uses a fixed centrifuge that can lead to slanted sample sediment, which can impact the sample quality.It was also found that several operator maintenance actions on the analyzer were due.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys vitamin b12 immunoassay results for 1 patient sample on a cobas pro ssu e 801 module.On (b)(6) 2024, the initial vitamin b12 result was 101 pg/ml.The sample was repeated and the result was 100 pg/ml with flag.The results were deemed incorrect.On (b)(6) 2024, the sample was repeated on an e601 analyzer.The initial vitamin b12 result was 201.8 pg/ml.The sample was repeated and the result was 178.4 pg/ml.The result of 201.8 pg/ml was deemed correct.No questionable results were reported outside of the laboratory.
Additional Manufacturer Narrative
Section d product information has been updated, as well as g1 manufacturing site and g4.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.

• Brand Name: ELECSYS VITAMIN B12 II
• Common Device Name: RADIOASSAY, VITAMIN B12
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 20170210
• Report Number: 1823260-2024-02594
• Device Sequence Number: 12824561
• Product Code: CDD
• UDI-Device Identifier: 04015630939848
• UDI-Public: 04015630939848
• Combination Product (Y/N): Y
• Initial Reporter Country: BR
• PMA/510(K) Number: K060755
• 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
• Report Date (Section B): 11/05/2024

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 Expiration Date: 10/31/2025
• Device Catalogue Number: 07028121190
• Device Lot Number: 769866
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/16/2024
• Supplement Date Received by Manufacturer: 10/16/2024
• Initial Report FDA Received Date: 09/09/2024
• Supplement Report FDA Received Date: 11/05/2024
• 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 Age: 70 YR
• Patient Sex: Female