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

Model Number VITD TOTAL

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/27/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter complained of discrepant results for 1 patient tested for vitamin d total (vitamin d) and elecsys vitamin d total ii (vitamin d ii) on a cobas 8000 e 602 module and a cobas e801 module.This medwatch will cover vitamin d.Refer to medwatch with patient identifier (b)(6) for information on the vitamin d ii results.The initial vitamin d ii result from the e801 module was 35.9 ng/ml.The sample was repeated using vitamin d on the e602 module and the result was 3.00 ng/ml.The customer re-centrifuged the sample and repeated it on the e602 module with a result of 6.52 ng/ml.The customer performed a 1:2 dilution and repeated the sample on the e602 module with a result of 26.7 ng/ml.The customer reported the vitamin d ii result of 35.9 ng/ml outside of the laboratory.It is not clear which results the customer believes to be correct.A new sample was obtained from the patient on (b)(6) 2019 and the vitamin d ii result from the e801 module was 66.5 ng/ml.The customer attempted to run this sample on the e602 module, however, an alarm message was received with no result.The customer observed a clot at the sipper probe.There was no allegation that an adverse event occurred.The e602 module serial number was (b)(4).The e801 module serial number was not provided.

Manufacturer Narrative

The customer testing a sample from the patient by liquid chromatography-tandem mass spectrometry (lcms/ms) and the vitamin d ii result was 21.67 ng/ml.The investigation tested a sample from the patient on an e801 module.The investigation was able to reproduce the customer's vitamin d and vitamin d ii results.The investigation tested this patient sample by the lcms/ms method and received a vitamin d ii result (18.9 ng/ml) that was comparable to the customer's lcms/ms result of 21.67 ng/ml.Investigations are ongoing.

Manufacturer Narrative

The investigation determined that the difference in results between vitamin d and vitamin d ii assays are related to an unknown issue with the patient sample; the patient is a cancer patient with an unknown blood composition.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: 8523509
• MDR Text Key: 142354730
• Report Number: 1823260-2019-01524
• 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,Followup
• Report Date: 07/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: VITD TOTAL
• Device Catalogue Number: 05894913190
• Device Lot Number: 35655502
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/27/2019
• Initial Date FDA Received: 04/17/2019
• Supplement Dates Manufacturer Received: 03/27/2019; 03/27/2019
• Supplement Dates FDA Received: 06/07/2019; 07/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1