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

Catalog Number 09038078190

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

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

Event Date 10/29/2021

Event Type  malfunction  

Manufacturer Narrative

Calibration signals were within expectations for e 602 analyzer serial number (b)(4).On e 602 analyzer serial number (b)(4), a fluctuation in calibration signals is seen between (b)(6) 2021.Many calibrations with 3 different reagent kits were done within a short time and signals were too low for the first calibrator level.On e 602 analyzer serial number (b)(4), calibration signals are sometimes slightly lower than expected.On e 602 analyzer serial number (b)(4), most quality control data is within range, with some high and low outliers observed.On e 602 analyzer serial number (b)(4), most quality control data is within range, with some results outside of range high.On e 602 analyzer serial number (b)(4), quality controls sometimes show higher fluctuations not only in (b)(6) 2021, but also in (b)(6) 2021.Both control levels have some results outside of range high or low.Sample centrifugation time was shorter and the speed was faster than recommended by the tube manufacturer.The investigation is ongoing.

Event Description

The initial reporter stated they have been receiving discrepant results for 70 patient samples tested with the elecsys vitamin d gen.3 assay.The discrepant results were measured on at least three different cobas 8000 e 602 module analyzers, serial numbers (b)(4).Incorrect results were reported outside of the laboratory to the clinician for sample 56.It was asked, but it is not known if incorrect results were reported outside of the laboratory for the remaining samples.

Manufacturer Narrative

The customer stated they received discrepant vitamin d results for an additional 34 patient samples (samples 71 - 104).The customer stated that some incorrect results from these samples were reported outside of the laboratory to clinicians, but the customer did not state which samples had incorrect results reported outside of the laboratory.Refer to the attachment for all patient data.

Manufacturer Narrative

Upon review of control data, sometimes values are outside of range and imprecision is seen.However, a major reagent issue is not evident as the cause of the issue.The sample centrifugation settings were not done according to instructions from the tube manufacturer and this may have an influence on sample quality and results.Upon review of sample images from foam detection cameras, sample quality issues in the laboratory were clearly observed as many samples showed fibrin and unknown particles on the surface.In addition, there were clot alarms and samples had bubbles.Contamination may also play a role in sample quality as dust was noticed in the laboratory and on analyzer components.Sample quality was also checked locally and a large number of samples tested had clear sample quality issues.Several instrument maintenance issues were identified and solved by multiple service actions done on all three e 602 analyzers.The sample throughput was too high for the current analyzer maintenance interval.The investigation could not identify a product problem.The cause of the event could not be determined.The issue is consistent with poor sample quality in combination with poor instrument maintenance.

Manufacturer Narrative

The evaluation conclusion code has been updated.

• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 13203110
• MDR Text Key: 288484818
• Report Number: 1823260-2022-00068
• Device Sequence Number: 1
• Product Code: MRG
• Combination Product (y/n): N
• Reporter Country Code: DA
• 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,Followup,Followup
• Report Date: 01/19/2023

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 Catalogue Number: 09038078190
• Device Lot Number: 55761701
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2021
• Initial Date FDA Received: 01/10/2022
• Supplement Dates Manufacturer Received: 01/13/2022; 11/02/2022; 01/18/2023
• Supplement Dates FDA Received: 02/02/2022; 11/07/2022; 01/19/2023
• 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