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

Catalog Number 07464215160

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/26/2021

Event Type  malfunction  

Manufacturer Narrative

The qc results were acceptable.The investigation is ongoing.Unique identifier (udi) #(b)(4).

Event Description

There was an allegation of questionable vitamin d total g2 elecsys results for one patient sample from cobas 6000 e601 module serial number (b)(4).The initial result was >100 ng/ml with a data flag.The customer said they would typically report it as >100 ng/ml, but in this case the tech requested a rerun with decreased sample volume.The rerun result was 51.74 ng/ml.Review of the result monitor printout for the result of 51.74 ng/ml determined result does not show either a "dec" for a decreased order or "1:2" for a 1:2 dilution.It appears to have been tested with a normal sample volume.However, the customer insisted the tech requested the repeat with a decreased sample volume.The customer then performed a manual 1:2 dilution and the result was 24.64 ng/ml, which would yield a final result of 49.28 ng/ml.Per product labeling, the concentration of the diluted sample must be > or = to 40 ng/ml.The customer then repeated the sample with no dilution and the result was >100 ng/ml with a data flag.The result of 51.74 ng/ml was reported out to the physician.On (b)(6) 2021, the sample was sent to another laboratory and tested on a cobas 8000 analyzer and the result was 39.4 ng/ml.

Manufacturer Narrative

The calibration recovery was found to be acceptable.Based on calibration and qc data a general reagent issue could be excluded.The instrument alarm trace contained an abnormal probe sucking error.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: 11341933
• MDR Text Key: 232324412
• Report Number: 1823260-2021-00505
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 04/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 07464215160
• Device Lot Number: 50317501
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LEVATHYROXIN NA.; VENLAFAXINE HCL.; VITAMIN B12.; VITAMIN D3.; LEVATHYROXIN NA.; VENLAFAXINE HCL.; VITAMIN B12.; VITAMIN D3.
• Patient Age: 24 YR