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

Catalog Number 07212771190

Device Problems High Test Results (2457); Low Test Results (2458); Non Reproducible Results (4029)

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

Event Date 07/12/2023

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) performed routine maintenance and service.The fse noted that the liquid flow cleaning (lfc) system was working fine.He performed mechanical and precision checks with successful results.The investigation excluded a general reagent problem.Based on the information provided, the investigation did not identify a product problem.The cause of the event could not be determined.

Event Description

The initial reporter received questionable elecsys vitamin b12 immunoassay results from two patient samples tested on the cobas e411 disk.The reporter was able to provide one example of a questionable result.The initial result was greater than 2000 pg/ml.The repeat result was 225.2 pg/ml.The repeat result was cross-checked on the laboratory's other e 411 and no significant variation was noted.

• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 17591119
• MDR Text Key: 321838805
• Report Number: 1823260-2023-02717
• Device Sequence Number: 1
• Product Code: CDD
• Combination Product (y/n): Y
• Reporter Country Code: IN
• 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
• Report Date: 08/21/2023

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: 07/26/2023
• Initial Date FDA Received: 08/21/2023
• 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