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

Catalog Number 09038086190

Device Problem High Test Results (2457)

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

Event Date 11/28/2023

Event Type  malfunction  

Event Description

The initial reporter alleged higher results for qc and patients after changing to a new reagent lot of elecsys vitamin d total iii (vitamin d total iii) on a cobas e 801 analytical unit.Of the data provided for 5 patient samples, the results for 1 patient sample were discrepant.The initial result using reagent lot 718894 was 14 ng/ml.The repeat result using the new reagent lot of 744661 was 23.2 ng/ml.

Manufacturer Narrative

The e801 analyzer serial number was (b)(6).The customer stated they are using reagent lot 744661 on a different system with no issues.The investigation is ongoing.

Manufacturer Narrative

For reagent lot 718894: calibration was last performed on 27-oct-2023 with acceptable results.For reagent lot 744661: calibration was last performed on 27-nov-2023 with acceptable results.Based on the calibration data, the reagents were not calibrated with a fresh calibrator directly before comparing the patient samples that were run on (b)(6) 2023.All qc results were acceptable.The investigation tested 6 different retention reagent lots with qc on an e801 module and an e602 module.The customer's observation was not reproduced.A human serum panel was also measured.The data generated at the investigation site (control recovery and patient samples) do not suggest a reagent issue.A review of worldwide qc recovery data does not suggest an issue.Based on the data available and the investigation results, the investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 18336901
• MDR Text Key: 330615844
• Report Number: 1823260-2023-04047
• Device Sequence Number: 1
• Product Code: MRG
• UDI-Device Identifier: 07613336172650
• UDI-Public: 07613336172650
• Combination Product (y/n): Y
• Reporter Country Code: NL
• 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,Followup
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 09038086190
• Device Lot Number: 744661
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2024
• 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