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 06/26/2023

Event Type  malfunction  

Manufacturer Narrative

The cobas e 801 immunoanalyzer serial number was (b)(6).The calibration signals for vitd3 assay are slightly lower than the expected ranges.Qc was a 3rd party qc and was within the customer's set range.Investigation is ongoing.

Event Description

We received an allegation of a high result not corresponding to the clinical picture for 1 patient's plasma sample tested with elecsys vitamin d total g3 (vitd3) assay on a cobas e 801 immunoanalyzer.Different sample draws were collected from the patient and were tested with 2 methods.The physician then compared the vitd3 result to a previous vitamin d g2 (vitd2) result and to a non-roche method where the patient did not receive any treatment.One month earlier, the vitd2 result was 33.1 ng/ml (tested on the same analyzer).On (b)(6) 2023, a new sample was collected and the vitd3 result was 54.3 ng/ml.On (b)(6) 2023 the same sample was repeated: before recalibration, the vitd3 result was 56.6 ng/ml.After recalibration, the vitd3 result was 53.2 ng/ml.The same sample was also repeated on a different e801 analyzer and the vitd result was 53 ng/ml.The vitd result from a non-roche (abbott) analyzer was 44.3 ng/ml (unknown which sample was tested).

Manufacturer Narrative

The investigation did not identify a product problem.The cause of the event could not be determined.Due to different standardizations between methods, result variation may arise.Each laboratory should investigate the transferability of the expected values to its own patient population and if necessary determine its own reference ranges.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings.

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 17383187
• MDR Text Key: 320662923
• Report Number: 1823260-2023-02423
• Device Sequence Number: 1
• Product Code: MRG
• UDI-Device Identifier: 07613336172650
• UDI-Public: 07613336172650
• Combination Product (y/n): N
• Reporter Country Code: TH
• 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: 08/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2023
• 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: 7011580
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2023
• 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