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

Catalog Number 07464215190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/24/2020

Event Type  malfunction  

Manufacturer Narrative

The customer stated all of the questionable results were run on a reagent pack that was almost empty; as soon as they put on a new reagent the issue was resolved.

Event Description

The initial reporter complained of questionable results for multiple patients tested for elecsys vitamin d total ii (vitamin d total ii) on a cobas 6000 e 601 module.The reporter provided an example of discrepant results for 1 patient sample.The initial result was > 170 ng/ul with a data flag.This result was reported outside of the laboratory where it was questioned.On (b)(6) 2020 the sample was repeated and the result was 27.29 ng/ul.The customer performed a x2 dilution and received a result of 55 ng/ul which was believed to be correct.The e601 module serial number was (b)(4).

Manufacturer Narrative

The field service engineer (fse) visited the customer site.The photo-multiplier tube high voltage was adjusted, the reagent probe was flushed and liquid flow cleaning was performed.Instrument test results were acceptable.The customer ran precision tests which were acceptable.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: 10283280
• MDR Text Key: 199690226
• Report Number: 1823260-2020-01718
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 07464215190
• Device Lot Number: 44685600
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 50 YR