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

Catalog Number 09038078190

Device Problem Chemical Problem (2893)

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

Event Date 02/01/2024

Event Type  malfunction  

Manufacturer Narrative

The analyzer serial number is (b)(6).The calibration and qc recovery data provided was acceptable.The field service engineer (fse) replaced the measuring cell and the bead mixer, and a precision check was performed successfully.The investigation is ongoing.

Event Description

There was an allegation of questionable elecsys vitamin d assay results for 1 patient sample on a cobas 6000 e601 module.The initial vitamin d result was 8.97 ng/ml.The sample was repeated on a cobas e411 analyzer and the result was 15.41 ng/ml.Clarification on what date the e411 result was from was not provided.The repeat result was deemed correct.

• Brand Name: ELECSYS VITAMIN D TOTAL III
• 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: 18807550
• MDR Text Key: 337001232
• Report Number: 1823260-2024-00597
• Device Sequence Number: 1
• Product Code: MRG
• Combination Product (y/n): Y
• Reporter Country Code: IN
• PMA/PMN Number: K210901
• 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: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 09038078190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2024
• 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