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

Model Number VITD TOTAL

Device Problem Incorrect Measurement (1383)

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

Event Date 03/25/2021

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Unique device identifier (udi) (b)(4).The customer confirmed the sample was not available for any additional repeat measurements.

Event Description

The initial reporter received questionable elecsys vitamin d assay results for one patient tested on a cobas e411 rack serial number (b)(6).The patient's initial vitamin d result was reported outside the laboratory.The patient's physician requested the patient's vitamin results.The customer collected a new sample from the patient on the same day as the initial sample, and the new sample was sent to an external laboratory.The sample was tested on an agilent technologies analyzer with liquid chromatography with tandem mass spectrometer (lc-ms) methodology.The patient's initial vitamin d result was 9.94 ng/ml.The patient's lc-ms total 25-oh-vitamin d result was 46.13 ug/l.

Manufacturer Narrative

The customer's calibration and qc results were ok.A general reagent issue can most likely be excluded.The investigation reviewed the system's alarm trace and no abnormalities were discovered.Based on the available information, the investigation did 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: 11712001
• MDR Text Key: 268526892
• Report Number: 1823260-2021-01222
• 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: 05/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: VITD TOTAL
• Device Catalogue Number: 05894913190
• Device Lot Number: 500101
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1