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

Model Number VITD TOTAL

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

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

Event Date 06/08/2021

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Unique identifier (udi): (b)(4).

Event Description

The initial reporter questioned high results for multiple patient samples tested for elecsys vitamin d total (vitamin d) on a cobas e 411 immunoassay analyzer.All vitamin d results with plasma samples were > 175 nmol/l.The customer didn't initially rerun any of the samples.The customer centrifuged 1 patient sample at 3000 rpm for 10 minutes and repeated it with a result of 71 nmol/l.The repeat result was believed to be correct.No questionable results were reported outside of the laboratory.The e411 analyzer serial number was (b)(4).

Manufacturer Narrative

Calibration signals were slightly lower than expected, however, this did not affect calibration performance.Qc was acceptable.The customer was centrifuging plasma samples for 4 minutes at 4500 rpm.This centrifugation time is too short and the speed is too high.The customer has been advised to centrifuge plasma samples for 10 minutes at 3000 rpm.The cause of the event could not be determined.Neither a general instrument or reagent issue were identified.The event is consistent with a pre-analytical handling issue at the customer site.

• 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: 12091084
• MDR Text Key: 271729249
• Report Number: 1823260-2021-01876
• 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: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: VITD TOTAL
• Device Catalogue Number: 05894913190
• Device Lot Number: 52073601
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1