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

Model Number VITD TOTAL

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/15/2021

Event Type  malfunction  

Manufacturer Narrative

Samples from the patients were requested for investigation.This event occurred in (b)(6).

Event Description

There was an allegation of questionable high elecsys vitamin d assay results for two patients (husband and wife) after being diagnosed with covid19.The initial results for both patients were >70 ng/ml with a data flag.The results using a 1:2 dilution were >70 ng/ml with a data flag.Calculated, the results would be at least 140 ng/ml.The results using a 1:5 dilution were >70 ng/ml with a data flag.Calculated, the results would be at least 350 ng/ml.On (b)(6) 2021, new samples were taken from both patients and the results were >70 ng/ml with a data flag.These samples were sent to another laboratory and tested on a beckman coulter dxl analyzer.The wife's result was 63.9 ng/ml and the husband's result was 58.2 ng/ml.The customer used cobas e411 rack analyzer serial number (b)(4).

Manufacturer Narrative

Samples from the patients were submitted for investigation.The customer's results after dilution could not be confirmed.The results obtained with a 1:2 dilution were comparable to the results from beckman.Per product labeling, samples with vitamin d concentrations above the measuring range can be manually diluted with diluent universal or a suitable human serum with a low analyte concentration.The recommended dilution is 1:2.The concentration of the diluted sample must be > 30.0 ng/ml.After manual dilution, multiply the results by the dilution factor.Automatic dilution by analyzer is not possible.Based on the investigation and product labeling for the assay, the issue was consistent with the customer performing an automatic dilution which is not possible with this assay where they would obtain a value > 70 ng/ml, no matter which dilution factor the customer selected.Assays from different manufacturers may generate different values.This related to the overall setups of the assays, the antibodies used and the standardization methodology/materials used.A general product problem was not found.

• Brand Name: ELECSYS VITAMIN D ASSAY
• Type of Device: VITAMIN D TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 11309273
• MDR Text Key: 268265522
• Report Number: 1823260-2021-00415
• Device Sequence Number: 1
• Product Code: MRG
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: K113546
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2021
• 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 Model Number: VITD TOTAL
• Device Catalogue Number: 05894913190
• Device Lot Number: 47547800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 29 YR