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

Catalog Number ASKU

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/06/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter stated that they have had ongoing issues with patient sample recovery for the elecsys vitamin d total gen.2 assay on the cobas 6000 e 601 module.The customer provided data for 19 patient samples with erroneous vitamin d results.Refer to the attachment for all patient data.It was asked, but it is not known if any erroneous results were reported outside of the laboratory.There was no allegation of an adverse event.The customer stated that they checked the reagents for bubbles prior to loading them on the analyzer.The serial number of the e 601 analyzer is (b)(4).

Manufacturer Narrative

The alarm trace showed no hint to an issue.The erroneous results occurred directly after a reagent change on (b)(6) 2019 at 18:00.It is unknown if the affected reagent kit had qc run after loading.Qc data was requested, but not provided by the customer.The root cause is consistent with bubbles or foam on the surface of a single reagent kit, which resulted in a mis-pipetting of reagent.

• Brand Name: ELECSYS VITAMIN D TOTAL II
• Type of Device: VITAMIN D TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 8472954
• MDR Text Key: 140621552
• Report Number: 1823260-2019-01315
• Device Sequence Number: 1
• Product Code: MRG
• Combination Product (y/n): N
• PMA/PMN Number: K162840
• 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: 06/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: 366696
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1