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 Consequences Or Impact To Patient (2199)

Event Date 11/18/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter stated they received a discrepant high result for one patient sample tested with the elecsys vitamin b12 immunoassay on a cobas 8000 e 801 module.The patient is approximately (b)(6).The sample resulted with a vitamin b12 value of > 2000 pg/ml accompanied by a data flag.This value was reported outside of the laboratory and doubted by the physician since the value did not fit the clinical picture of the patient.No vitamin b12 had been administered to the patient either orally or parenterally.The patient's high vitamin b12 levels have been reproducible over a period of over six months.The e 801 analyzer serial number is (b)(4).

Manufacturer Narrative

The calibration data was checked and was ok.Calibration signals were found to be slightly lower than expected.Quality controls recovered within range on the day of the event.The patient sample was provided for investigation.The values generated at the customer site could be duplicated.Further investigations of the sample revealed it contains an igg interferent.Product labeling states: "in rare cases, interference due to extremely high titers of antibodies to analyte specific antibodies, streptavidin or ruthenium can occur.These effects are minimized by suitable test design.".

• Brand Name: ELECSYS VITAMIN B12 II
• Type of Device: RADIOASSAY, VITAMIN B12
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 9473462
• MDR Text Key: 219212215
• Report Number: 1823260-2019-04427
• Device Sequence Number: 1
• Product Code: CDD
• Combination Product (y/n): N
• PMA/PMN Number: K060755
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 04/02/2020

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: 413014
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/20/2019
• Initial Date FDA Received: 12/16/2019
• Supplement Dates Manufacturer Received: 11/20/2019
• Supplement Dates FDA Received: 04/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NO MEDICATION.