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

Model Number VITD TOTAL

Device Problems Low Test Results (2458); Non Reproducible Results (4029)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/15/2021

Event Type  malfunction  

Manufacturer Narrative

The customer recalibrated the test and ran controls.Controls recovered within range.Patient samples 1-7 were then repeated.Refer to the attachment for the repeat values.The repeat values were in line with the clinical picture of the patients.

Event Description

The initial reporter stated they received discrepant results for eight patient samples tested with the elecsys vitamin d assay on a cobas e 411 immunoassay analyzer.No incorrect results were reported outside of the laboratory.Refer to the attachment for data from patient samples 1-7.All seven samples initially resulted in vitamin d values of < 3 ng/ml.To check if there were problems, the customer pulled a sample (sample 8) that had a validated result value of 43.89 ng/ml on (b)(6) 2021 and repeated it.The repeat result from this 8th sample was 6.46 ng/ml.The serial number of the e 411 analyzer is (b)(4).

Manufacturer Narrative

Medwatch field g4.Has been updated.

Manufacturer Narrative

Data was provided for 5 additional patient samples which had discrepant vitamin d results.The following data for these samples was provided: additional sample 1; run 1 = 8.87 ng/ml, run 2 = 56.9 n/ml.Additional sample 2; run 1 = < 3 ng/ml accompanied by a data flag, run 2 = 17.51 ng/ml.Additional sample 3; run 1 = 3.41 ng/ml, run 2 = 30.53 ng/ml.Additional sample 4; run 1 = < 3 ng/ml accompanied by a data flag, run 2 = 28.82 ng/ml.Additional sample 5; run 1 = 43.89 ng/ml, run 2 = 6.46 ng/ml, run 3 = 47.55 ng/ml.For this new patient data, no incorrect results were reported outside of the laboratory.

Manufacturer Narrative

For a calibration occurring on (b)(6)-2021, calibration signals for one calibrator level were within expected values.The signals for the second calibrator level were higher than expected.A new calibration performed on (b)(6)2021 with a different reagent pack had signals that were higher than expected.A new calibration performed on (b)(6)-2021 with the previous reagent pack had signals that were higher than expected.One control level was outside of range on (b)(6)-2021 and (b)(6)-2021.The second control level was within range, but borderline high on (b)(6)-2021.The second control level was within range on (b)(6)-2021 and (b)(6)-2021.The customer stored the reagent alternatively both on the analyzer and in the laboratory refrigerator.Upon review of the alarm trace, no relevant alarms were observed.The investigation could not identify a product problem.The cause of the event could not be determined.

• 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
• MDR Report Key: 12187671
• MDR Text Key: 262186505
• Report Number: 1823260-2021-02072
• 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,Followup,Followup
• Report Date: 09/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: VITD TOTAL
• Device Catalogue Number: 05894913190
• Device Lot Number: 52073601
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/01/2021
• Initial Date FDA Received: 07/19/2021
• Supplement Dates Manufacturer Received: 06/16/2021; 06/16/2021; 06/16/2021
• Supplement Dates FDA Received: 07/30/2021; 08/25/2021; 09/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1