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

Catalog Number 07464215190

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/28/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter stated that they noticed an issue with one reagent kit of the elecsys vitamin d total gen.2 assay on the cobas 8000 e 602 module.An unspecified number of patient samples resulted with values of > 250 nmol/l and when repeated on another analyzer, results were within the technical limit of the assay.The customer provided data for a total of 36 patient samples and of these, one had an erroneous vitamin d result.The erroneous result was not reported outside of the laboratory.The sample initially resulted with a value of 88.89 nmol/l when measured with the problematic kit.When tested on the other analyzer, the vitamin d result was 48.98 nmol/l.No adverse events were alleged to have occurred with the patient.The e 602 analyzer serial number is (b)(4).

Manufacturer Narrative

The performance testing data indicates a contamination of the analyzer¿s fluidic system and sipper probes.Based on the data provided, the investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 8472957
• MDR Text Key: 140621744
• Report Number: 1823260-2019-01317
• 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: 09/23/2019

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: 07464215190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1