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

Catalog Number 07028148190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/26/2020

Event Type  malfunction  

Manufacturer Narrative

This investigation is ongoing.This event occurred in (b)(6).

Event Description

The initial reporter received questionable elecsys vitamin d total ii results for two patients with the cobas e 801 module serial number (b)(4).The initial result was > 100.The customer reran with auto dilution twice with results of 32.6 and 34.3 respectively.The sample was then rerun without dilution with a result of 28.5.The customer also mentioned that two weeks prior, a similar questionable result occurred with an initial result of >100 and a repeated result of 29.It unclear whether these were the same or different patients.The unit of measure was requested but not provided.The questionable results were not reported outside the laboratory.

Manufacturer Narrative

The calibration signals are on the lower end of expectations.The qc recovery was acceptable.The alarm trace was requested but not provided.There was no indication of a reagent issue.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: 11055042
• MDR Text Key: 244803002
• Report Number: 1823260-2020-03318
• 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: 02/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: 07028148190
• Device Lot Number: 484711
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1