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

Catalog Number 07028121190

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/18/2023

Event Type  malfunction  

Manufacturer Narrative

The analyzer serial number is (b)(6).The patient samples were requested for investigation.The investigation is ongoing.

Event Description

There was an allegation of questionable elecsys vitamin b12 immunoassay results for 2 patient samples on a cobas e 801 analytical unit.On (b)(6) 2023, the initial b12 result was 1693 pg/ml.The doctor questioned the result as it did not match the patient's clinical picture.On (b)(6) 2023, a new sample was collected and the result was 1636 pg/ml.

Manufacturer Narrative

The patient samples were received for investigation.The customer's high vitamin b12 result was able to be confirmed and no interfering factor was identified in the patient sample.The investigation did not identify a product problem.The root cause of the event could not be determined.

• Brand Name: ELECSYS VITAMIN B12 II
• Type of Device: 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: 18363318
• MDR Text Key: 330977915
• Report Number: 1823260-2023-04127
• Device Sequence Number: 1
• Product Code: CDD
• UDI-Device Identifier: 04015630939848
• UDI-Public: 04015630939848
• Combination Product (y/n): Y
• Reporter Country Code: IT
• PMA/PMN Number: K060755
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/01/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 07028121190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2023
• Initial Date FDA Received: 12/20/2023
• Supplement Dates Manufacturer Received: 02/21/2024
• Supplement Dates FDA Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 4 YR
• Patient Sex: Male