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

Model Number VITD TOTAL

Device Problem High Test Results (2457)

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

Event Date 06/09/2021

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Udi number = (b)(4).

Event Description

The initial reporter stated they received discrepant results for two patient samples tested with the elecsys vitamin d assay on a cobas e 411 immunoassay analyzer (serial number (b)(4)).The second sample also had a discrepant vitamin d result when tested on a cobas 8000 e 602 module.The first sample initially resulted in a vitamin d value of > 70.00 ng/ml when tested on the e411 analyzer.The sample was repeated in a second laboratory using an unknown chemiluminescence method, resulting in a value of 32.04 ng/ml.The 32.04 ng/ml value was believed to be correct.The sample was repeated on the customer's e411 analyzer on (b)(6) 2021, resulting in a value of 68.05 ng/ml.No incorrect results were reported outside of the laboratory for this sample.The second sample initially resulted in a vitamin d value of > 70 ng/ml when tested on the e411 analyzer on (b)(6) 2021.The sample was sent to another laboratory for testing on an architect analyzer, resulting in a value of 15.3 ng/ml on (b)(6) 2021.An aliquot of the sample was repeated on the e411 after re-centrifugation, resulting in a value of 67.5 ng/ml on (b)(6) 2021.The aliquot was also tested on an e 602 analyzer, resulting in a value of 160 nmol/l on (b)(6) 2021.It was asked, but unknown if any incorrect results were reported outside of the laboratory for this sample.

Manufacturer Narrative

There were no alarms for the last calibration occurring on (b)(6) 2021.Quality controls were within range, showing no indication of a reagent or instrument performance issue.Upon review of the alarm trace, an insufficient sample volume alarm and a clot pipetting alarm occurred on the day of the event near the time the sample was processed.This is an indication of poor sample quality.The investigation could not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS VITAMIN D ASSAY
• Type of Device: VITAMIN D TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 12084996
• MDR Text Key: 271722212
• Report Number: 1823260-2021-01870
• Device Sequence Number: 1
• Product Code: MRG
• Combination Product (y/n): N
• PMA/PMN Number: K113546
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: VITD TOTAL
• Device Catalogue Number: 05894913190
• Device Lot Number: 54367601
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1