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

Catalog Number 09038086190

Device Problems Low Test Results (2458); Non Reproducible Results (4029)

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

Event Date 12/20/2023

Event Type  malfunction  

Manufacturer Narrative

The cobas e801 module unit 2 serial number was (b)(6).Qc was out of range on the day of the event, however, the patient sample was measured before the qc results were out of range.The field service engineer (fse) found that the amount of procell liquid in the reservoir area did not reach the required volume.The procell suction failure was caused by a clog in the tube.The fse cleaned the tubes' flow paths and the sipper probe.The cleaning of the flow paths showed that the cleaning water that passed through the nozzle contained small foreign particles.The service action (cleaning the flow path) resolved the issue.It was suspected that sample gelation occurred.The patient's sample was requested for investigation.The investigation is ongoing.

Event Description

We received an allegation about discrepant results for 1 patient's sample tested with elecsys vitamin d total g3 (vitamin d total iii) assay on a cobas 8000 e801 immunoassay analyzer (unit 2) when compared to a different cobas 8000 e801 immunoassay analyzer (unit 1).Initial test: 24.7 ng/ml (unit 2).No questionable result was reported outside the laboratory as the initial result did not match the patient's previous results.The sample was then repeated.1st repeat result: 41.2 ng/ml (unit 1).2nd repeat result: 35.1 ng/ml (unit 1).The 2nd repeat result of 35.1 ng/ml was believed to be correct.

Manufacturer Narrative

The patient's sample tested at the customer's site was a serum sample.On the day of the event, the qc was acceptable in the morning while it went higher in the afternoon.The sample was received for investigation on (b)(6) 2024.The provided diagnostic data showed that the patient's protein level was elevated.The investigation is ongoing.

• 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: 18508206
• MDR Text Key: 332816323
• Report Number: 1823260-2024-00136
• Device Sequence Number: 1
• Product Code: MRG
• UDI-Device Identifier: 07613336172650
• UDI-Public: 07613336172650
• Combination Product (y/n): Y
• Reporter Country Code: JA
• 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: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• 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: 01/18/2024
• 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