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

Catalog Number 07212771190

Device Problems Low Test Results (2458); Non Reproducible Results (4029)

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

Event Date 07/10/2023

Event Type  malfunction  

Event Description

The initial reporter complained of discrepant results for 1 patient sample tested for elecsys vitamin b12 ii (vitamin b12 ii) on a cobas e 411 immunoassay analyzer.The initial result was 112.1 pg/ml.The sample was repeated twice with results of 147.0 pg/ml and 247 pg/ml.No questionable results were reported outside of the laboratory.

Manufacturer Narrative

The e411 analyzer serial number was (b)(6).The calibration and qc data do not suggest a general reagent issue.Several sample pipetting alarms were observed on the alarm trace data.Reagent pipetting alarms were also noted.Liquid flow cleaning was last performed on (b)(6) 2023.The investigation is ongoing.

Manufacturer Narrative

Based on the calibration and qc data, a general reagent issue is not suspected.The investigation did not identify a product problem.The 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg)
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250-0457
• MDR Report Key: 17454920
• MDR Text Key: 320415904
• Report Number: 1823260-2023-02511
• Device Sequence Number: 1
• Product Code: CDD
• Combination Product (y/n): Y
• Reporter Country Code: GR
• 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: 08/29/2023

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: 07212771190
• Device Lot Number: 707331
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/11/2023
• Initial Date FDA Received: 08/03/2023
• Supplement Dates Manufacturer Received: 08/16/2023
• Supplement Dates FDA Received: 08/29/2023
• 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