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

Catalog Number 09038078190

Device Problems Incorrect Measurement (1383); High Test Results (2457)

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

Event Date 05/04/2023

Event Type  malfunction  

Manufacturer Narrative

As a precautionary measure, the customer performed cleaning maintenance on the e 602 analyzer.After maintenance actions were carried out, controls were run and were in acceptable limits.Vitamin d testing at both laboratories was stopped.Upon initial investigation, it was determined that the customer site uses a fixed bucket centrifuge.Fixed bucket centrifuges cause a separation of the tube gel layer so that it becomes diagonal in the tube.This may cause aspiration of gel in the analyzer.Initial investigations determined the "patient zero" samples have a very high protein concentration (hyperproteinemia).The investigation is ongoing.

Event Description

The initial reporter stated they received questionable results for approximately 74 patient samples tested with elecsys vitamin d total iii.Some of these samples were tested on the customer's cobas 8000 e 602 module serial number (b)(6) and others on cobas e411 disk analyzer serial number (b)(6) at a second site.All questionable results were reported outside of the laboratory.The issue allegedly occurred after samples from one patient referred to as "patient zero" were tested on each system.Patient samples pipetted after the "patient zero" samples had discrepant vitamin d results.It is alleged that the "patient zero" samples may have contained an interferent or contaminant which caused an issue with the flow path of the measuring cell.At the customer site, vitamin d was calibrated on the e 602 system on (b)(6) 2023 and controls were tested.The calibration and controls were acceptable.A first sample from "patient zero" was tested at the customer site on the e 602 analyzer.The edta tube of this sample had discrepant results for the elecsys pth stat immunoassay.A questionable pth result from this sample was reported outside of the laboratory.This edta tube initially resulted in a pth value of 1.02 pmol/l and it repeated with values of 0.421 pmol/l and 0.374 pmol/l.The serum indices for this sample were measured five times and each time, there were no results, only flags indicating a sample clot.A second tube of this sample was tested for vitamin d 6 times and five of these measurements also had no results, only flags indicating a sample clot.A sixth measurement of this second tube had a vitamin d value of > 120.0 ng/ml with a data flag.This medwatch will apply to the vitamin d assay.Refer to the medwatch with a1.Patient identifier (b)(6) for information related to the pth assay.Approximately 34 patient samples pipetted after the "patient zero" sample had questionable vitamin d results.Refer to the table labeled "event 1" in the attachment for examples of data provided from these samples.These samples were all tested using the same vitamin d reagent pack.When the analyzer changed over to a new reagent pack, the issue no longer occurred.The customer laboratory sent patient samples to a second site for testing on (b)(6) 2023.A second sample from "patient zero" was also included in these samples.Approximately 40 samples pipetted after this "patient zero" sample had questionable values when tested on the e411 analyzer at this second site.Refer to the table labeled "event 2" in the attachment for examples of data provided from these samples.Some of these samples were also repeated on the customer's e 602 analyzer.

Manufacturer Narrative

The last vitamin d calibration occurred on 04-may-2023 and was acceptable.Quality controls were acceptable on the day of testing and continue to be acceptable.The data does not point to a general instrument or reagent issue.Upon review of the alarm trace, multiple abnormal sample aspiration alarms occurred on the date of the event.This means that a sample clot or inadequate sample volume was detected during aspiration.A mechanism check was performed on the analyzer and no abnormalities were seen.Precision studies were performed and all controls recovered within range.Based on this data, a general instrument issue could be excluded.A sample from "patient zero" was requested for investigation, but not provided.The amount of igg within this sample (igg: 101.0 g/l) was also found to be significantly above the claimed igg threshold for the elecsys vitamin d total iii assay (igg: = 70 g/l).The vitamin d total assay was not designed for measuring samples with such high igg concentrations.Sample photos provided indicate a possible pre-analytic handling issue.The investigation could not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS VITAMIN D TOTAL III
• 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 17052582
• MDR Text Key: 316447243
• Report Number: 1823260-2023-01812
• Device Sequence Number: 1
• Product Code: MRG
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K210901
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 09038078190
• Device Lot Number: 701287
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2023
• 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 Sex: Female