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

Catalog Number 07464215190

Device Problems High Test Results (2457); Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/24/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter complained of discrepant results for 1 patient sample tested for elecsys vitamin d total ii (vitamin d total ii) on a cobas 6000 e 601 module compared to the diasorin liasion method.The initial result from the e601 module was 100.0 ng/ml with a data flag.The repeat result from the e601 module was 32.69 ng/ml.The sample was repeated by the diasorin method with results of 8.41 ng/ml and 7.90 ng/ml.No questionable results were reported outside of the laboratory.The e601 module serial number was (b)(4).

Manufacturer Narrative

Qc recovery was within range but higher than the target value on the date of the event.Calibration recovery was requested but not provided.There was no indication for a performance issue of reagent or instrument.The alarm trace from the analyzer included an abnormal sample aspiration alarm, indicating poor sample quality.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: 10692183
• MDR Text Key: 219190628
• Report Number: 1823260-2020-02569
• 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: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 07464215190
• Device Lot Number: 48468803
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1