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

Model Number B12 G2

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/21/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter stated they received discrepant results for two patient samples tested with the elecsys vitamin b12 immunoassay on a cobas 6000 e 601 module.It was asked, but it is not known if any incorrect results were reported outside of the laboratory.The first patient sample initially resulted with a vitamin b12 result of 55.20 pg/ml and this repeated as 94.20 pg/ml.The sample was repeated on a siemens instrument, resulting with a value of 185.00 pg/ml.The second patient sample initially resulted with a vitamin b12 result of 50.00 pg/ml accompanied by a data flag and this repeated as 60.27 pg/ml.The sample was repeated on a siemens instrument, resulting with a value of 199.00 pg/ml.The serial number of the e 601 analyzer is (b)(4).

Manufacturer Narrative

Section d4, expiration date was updated.The siemens instrument is a siemens atelica.The values from the siemens instrument were reported outside of the laboratory to the patients.The last calibration was performed on (b)(6) 2020 and calibration signals were within expectation.Per product labeling, renewed calibration is recommended after 7 days when using the same reagent kit on the analyzer.Only one level of quality control was tested and this was within range.Per product labeling: "controls for the various concentration ranges should be run individually at least once every 24 hours when the test is in use, once per reagent kit, and following each calibration." upon review of the alarm trace, an abnormal sample aspiration alarm was observed.The investigation could not identify a product problem.The cause of the event could not be determined.Assays from different vendors can generate different values.This relates to the overall setups of the assays, the antibodies used, differences in reference materials/methods, and differences in the standardization methodology used.

• 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: 10546983
• MDR Text Key: 207540089
• Report Number: 1823260-2020-02286
• 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: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: B12 G2
• Device Catalogue Number: 07212771190
• Device Lot Number: 445835
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1