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

Model Number B12 G2

Device Problem High Test Results (2457)

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

Event Date 09/22/2021

Event Type  malfunction  

Manufacturer Narrative

Quality control results were in the acceptable range.Vitamin supplementation was ruled out.Sample from the patient was submitted for investigation.

Event Description

There was an allegation of questionable elecsys vitamin b12 immunoassay results from cobas 6000 e 601 module serial number (b)(4).The initial result was >2000 pg/ml.When diluted 1/2 manually, the result was 2376 pg/ml.The high result was reported outside of the laboratory and the physicians believed the high results (>2000 pg/ml) may be due to interference.The presence of immunoglobulin-vitamin b12 complexes (macro-b12) was suspected.The sample was processed again with a dilution with peg (1:1), obtaining a recovery of 17% (398 pg/ml) compared to a control sample with b12 also elevated which recovered 80%.

Manufacturer Narrative

The sample was investigated with size exclusion chromatography (sec) and showed more of an atypical distribution of vitamin b12 bound to binding proteins.This is consistent with an igg interference (macrob12) in addition to high free vitamin b12 and holotc concentrations.This interference is documented in product labeling for the assay: note: the presence of immunoglobulin-vitamin b12 complexes may cause unexpectedly high values of vitamin b12.Based on the available data, no product problem could be found.Section d4, expiration date was 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 12666805
• MDR Text Key: 277709017
• Report Number: 1823260-2021-03070
• Device Sequence Number: 1
• Product Code: CDD
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 11/24/2021

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 Expiration Date: 04/30/2022
• Device Model Number: B12 G2
• Device Catalogue Number: 07212771190
• Device Lot Number: 541427
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/29/2021
• Initial Date FDA Received: 10/20/2021
• Supplement Dates Manufacturer Received: 11/05/2021
• Supplement Dates FDA Received: 11/24/2021
• 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
• Patient Age: 65 YR
• Patient Sex: Female