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

Model Number B12 G2

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

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

Event Date 06/16/2023

Event Type  malfunction  

Event Description

The initial reporter received questionable elecsys vitamin b12 ii (vitamin b12 ii) results from four patient samples tested on the cobas e411 disk.The reporter was able to provide three examples of discrepant results: on (b)(6) 2023: the initial results were not reported outside of the laboratory.The reporter deemed the initial results too low which prompted the rerun of the patient samples.Sample 1 the initial result was 130.2 pg/ml.The repeat result was 214.9 pg/ml.Sample 2 the initial result was 93.06 pg/ml.The repeat result was 198.2 pg/ml.On (b)(6) 2023: the initial result was not reported outside of the laboratory.The reporter deemed the initial result high which prompted the rerun of the patient sample.Sample 3 the initial result was >2000 pg/ml.The first repeat result was 410.9 pg/ml.The second repeat result was 314.6 pg/ml.The third repeat result was 339.2 pg/ml.

Manufacturer Narrative

The serial number of the cobas e411 disk is (b)(6).The field service engineer (fse) inspected the analyzer and performed an assay performance test.The fse changed the sample and reagent probes.The customer used a new reagent pack and performed a calibration with successful results.The investigation is ongoing.

Manufacturer Narrative

The field service engineer (fse) replaced the defective measuring cell.After service, no further issues were reported by the customer.The investigation determined the service actions resolved the issue.The investigation determined that the event was caused by the defective measuring cell.

• 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: 17317238
• MDR Text Key: 319205131
• Report Number: 1823260-2023-02244
• Device Sequence Number: 1
• Product Code: CDD
• Combination Product (y/n): N
• 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: 09/07/2023

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 Model Number: B12 G2
• Device Catalogue Number: 07212771190
• Device Lot Number: 70733100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/16/2023
• Initial Date FDA Received: 07/13/2023
• Supplement Dates Manufacturer Received: 09/04/2023
• Supplement Dates FDA Received: 09/07/2023
• 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