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

Catalog Number	07028121190
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer's serial number is (b)(6).The alarm trace showed several "sample short", "procell short", and "cleancell short" alarms.The calibration results are acceptable.The qc shows unstable performance with multiple high out-of-range values.The field service representative performed maintenance tasks including primes, cleanings, and air purges.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys vitamin b12 ii results for 2 patient samples on a cobas e 801 analytical unit.Patient 1: the initial result was 100 pg/ml with a data flag.The sample was repeated and the result was 100 pg/ml with a data flag.A 1:2 dilution was performed and the result was 200 pg/ml with a data flag.A 1:10 dilution was performed and the result was 1000 pg/ml with a data flag.On (b)(6) 2024, the repeated result was 100 pg/ml with a data flag a 1:50 dilution was performed and the result was 104 pg/ml with a data flag.This result was reported outside the laboratory.Patient 2: on (b)(6) 2024, the initial result was 100 pg/ml with a data flag.The sample was repeated with an onboard dilution (1:10) on another module and the result was >1476 pg/ml with a data flag.This result was reported outside the laboratory.A manual 1:5 dilution was performed and the result was 500 pg/ml.
Additional Manufacturer Narrative
D4 expiration date was updated.The investigation found that the issue likely occurred because of settings on the infinity software, which may have limited the information displayed.It was confirmed that there are three settings which may impact how results are displayed on the user interface: rule engine, alphanumeric transformation, and result range transformation.The customer's data files were requested, but the files were unable to be obtained for review.The software performed within specification.The investigation did not identify a product problem.

• 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
• MDR Report Key: 20789485
• Report Number: 1823260-2024-03453
• Device Sequence Number: 18116576
• Product Code: CDD
• UDI-Device Identifier: 04015630939848
• UDI-Public: 04015630939848
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 03/03/2025

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: 04/30/2026
• Device Catalogue Number: 07028121190
• Device Lot Number: 79098900, 80857300
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/31/2024
• Supplement Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 11/26/2024
• Supplement Report FDA Received Date: 03/03/2025
• 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: 87 YR
• Patient Sex: Male