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

Catalog Number	07028121190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the customer's cobas e 801 analytical unit is (b)(6).The patient sample was requested for investigation.The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable elecsys vitamin b12 ii (b12 ii) results from two samples from the same patient tested on the cobas e 801 analytical unit.The reporter stated that the clinician asked if known interference factors were present because the results were too high and did not match the clinical picture for pernicious anemia.On (b)(6) 2024: the result was 977 ng/l.On (b)(6) 2024: the result was 1082 ng/l.
Additional Manufacturer Narrative
The patient sample was received for investigation.The patient sample was tested for the presence of an interferent; an interferent was not detected.The patient sample was tested for reactivity for vitamin b12 mainly bound to haptocorrin and transcobalamin ii and reactivity was detected.A high reactivity for unbound vitamin b12 was also detected.The patient sample was further tested in an external laboratory using a non-roche method and the high vitamin b12 value could not be confirmed.Product labeling states "for diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings." the investigation did not identify a product problem.The 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
• MDR Report Key: 19719188
• Report Number: 1823260-2024-01985
• Device Sequence Number: 18190400
• Product Code: CDD
• UDI-Device Identifier: 04015630939848
• UDI-Public: 04015630939848
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• 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 Catalogue Number: 07028121190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/18/2024
• Supplement Date Received by Manufacturer: 10/18/2024
• Initial Report FDA Received Date: 07/11/2024
• 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 Sex: Unknown