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 Consequences Or Impact To Patient (2199)

Event Date 05/27/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation determined an incorrect dilution for sample 1 was used.The investigation is ongoing.This event occurred in (b)(6).

Event Description

The initial reporter complained of questionable elecsys vitamin d assay results for 2 patient samples tested on a cobas 6000 e 601 module serial number (b)(4) compared to abbott and seimens methods.For sample 1 the initial vitamin d result was >70 ng/ml on the e 601 and the repeat result with a 1:20 dilution was 380 ng/ml.The abbott result was 34.8 ng/ml and the seimens result was 34.1 ng/ml.The field application specialist (fas) calibrated and the qc was acceptable.The fas repeated sample 1 and the vitamin d results were 69 ng/ml and 68 ng/ml.The customer reported a vitamin d result of 69.2 ng/ml outside of the laboratory.For sample 2 the initial vitamin d result was >70 ng/ml on the e 601 and the repeat result was 60.2 ng/ml.The abbott result was 42 ng/ml.No questionable results were reported outside of the laboratory.There was no allegation of an adverse event.

Manufacturer Narrative

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: 8771585
• MDR Text Key: 150424130
• Report Number: 1823260-2019-02453
• 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: 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: VITD TOTAL
• Device Catalogue Number: 05894913190
• Device Lot Number: 37353201
• Date Manufacturer Received: 06/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1