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

Model Number B12 G2

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458); No Apparent Adverse Event (3189); Non Reproducible Results (4029)

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

Event Date 02/05/2023

Event Type  malfunction  

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with the elecsys vitamin b12 immunoassay on a cobas e 411 immunoassay analyzer.No questionable results were reported outside of the laboratory.The sample initially resulted in a vitamin b12 value of < 37 pmol/l with a flag.The sample was repeated, resulting in a value of 360 pmol/l.

Manufacturer Narrative

The repeat vitamin b12 value of the sample was 360.3 pmol/l.The sample was initially tested on (b)(6) 2023.The provided quality control data from 07-feb-2023 was within range.The control lot used for the vitamin b12 assay was expired.Controls were being run as patient samples.The last calibration performed on (b)(6) 2023 had calibration signals that were within expectations.The customer used cups that are not specified for use on the analyzer.The sample rotor did not have adapters required for 13 mm.Diameter tubes.The analyzer measuring cell was overdue to be changed.Performance testing was within specifications.The investigation could not identify a product problem.The cause of the event could not be determined.The issue is consistent with incorrect pre-analytic sample handling, use of expired control material, use of cups not specified for use, and maintenance issues.Medwatch fields b3, d1, d2, d4, g1, and g4 have been updated.

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16504326
• MDR Text Key: 311130923
• Report Number: 1823260-2023-00724
• Device Sequence Number: 1
• Product Code: CDD
• Combination Product (y/n): N
• Reporter Country Code: SF
• 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: 04/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B12 G2
• Device Catalogue Number: 07212771190
• Device Lot Number: 661907
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1