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

Catalog Number 09038086190

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

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

Event Date 11/24/2023

Event Type  malfunction  

Manufacturer Narrative

The cobas pure e 402 analytical unit serial number was (b)(6).The qc and calibration results were within specifications.Therefore a general reagent issue could be excluded.The customer found a cap in the reagent carousel that appeared to be from the pretreatment reagent.The investigation is ongoing.

Event Description

There was an allegation of questionable vitamin d total g3 elecsys e2g results from the cobas pure e 402 analytical unit.The initial result was 120 ng/ml with a data flag.The automatic repeat with a 1:2 dilution was 16.6 ng/ml.The second repeat result was 19.2 ng/ml.

Manufacturer Narrative

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: 18334250
• MDR Text Key: 330593637
• Report Number: 1823260-2023-04023
• Device Sequence Number: 1
• Product Code: MRG
• UDI-Device Identifier: 07613336172650
• UDI-Public: 07613336172650
• Combination Product (y/n): Y
• Reporter Country Code: FR
• 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: 12/22/2023

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: 74466101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2023
• 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