MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS VITAMIN D TOTAL; VITAMIN D TEST SYSTEM

Catalog Number 05894913190

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

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

Event Date 11/20/2023

Event Type  malfunction  

Event Description

There was an allegation of questionable elecsys vitamin d assay results for 1 patient sample on a cobas e 411 immunoassay analyzer.The initial vitamin d result was >70.00 ng/ml.The doctor questioned the result and the sample was repeated.The repeat result was 10 ng/ml.The patient had a second sample collected and the vitamin d result was 8 ng/ml.

Manufacturer Narrative

The analyzer serial number is (b)(6).The qc recovery data provided was acceptable.The field service engineer (fse) checked the analyzer and found that it was in good condition.The investigation is ongoing.

Manufacturer Narrative

Based on the qc data provided, a general reagent issue could be excluded.The investigation did not identify a product problem.The root cause of the event could not be determined.

• Brand Name: ELECSYS VITAMIN D TOTAL
• Type of Device: VITAMIN D TEST SYSTEM
• 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: 18454025
• MDR Text Key: 332287233
• Report Number: 1823260-2024-00048
• Device Sequence Number: 1
• Product Code: MRG
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: K113546
• 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: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05894913190
• Device Lot Number: 733368
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1