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

Catalog Number 09038078190

Device Problems High Test Results (2457); Low Test Results (2458); High Readings (2459); Low Readings (2460)

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

Event Date 07/12/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.

Event Description

The initial reporter received questionable elecsys vitamin d total gen.3 assay results for around 71 patient samples tested on the cobas 8000 - cobas e 602 module with serial number (b)(4).The initial results were reported outside of the laboratory.On (b)(6) 2022, the reported reagent pack was at first in standby mode.The qcs were too low but were within range after recalibration.Patient samples were run when this reagent pack became current.The reporter observed that the patient results were high.The average result of this reagent pack was 174 nmol/l (b)(4).The results were compared to the previous reagent pack used which had an average of 67 nmol/l (n = 51) and the next reagent pack used which had an average of 71 nmol/l (b)(4).On (b)(6) 2022, the qc was within range for the reported reagent pack.The reporter removed this reagent pack due to the high test results.The patient samples were no longer available for reruns when the issue was discovered 2 weeks later.The patient results were also withdrawn 2 weeks after the initial reporting.The lot number of the previous and the next reagent pack the reporter used was 63009800.The expiration date was requested but not provided.

Manufacturer Narrative

Based on the qc data on the morning of 12-jul-2022, it can be deduced that there were two packs of reagent lot 622304 in the analyzer as there were two sets of results per qc level.One set of qc data was within range, and one set was reproducibly low out of range (it was assumed this is the complained reagent pack).The lot calibration with the complained reagent pack on 12-jul-2022 showed signals that were unusually high.The qcs were within range.During the period of the complained patient results (12-jul-2022 17:02 to 13-jul-2022), there was only one qc level measured on 12-jul-2022 in the afternoon, and one set of qc measurements (all levels) in the morning on 13-jul-2022.The qcs were within range.It seems that only one pack of reagent lot 622304 was controlled during this period.Because the reagent pack used for the qcs was not available, the investigation was unable to confirm if the reagent pack that was used for the complained results was controlled after the calibration.Product labeling states "controls for the various concentration ranges should be run individually at least once every 24 hours when the test is in use, once per reagent kit, and following each calibration." the qc recovery data for lot number 622304 did not show any general reagent issue.The investigation determined that based on the available information, the complained issue is likely related to a failure of a single kit of vitamin d total iii with lot number 622304.A general reagent issue can be excluded as other kits from the same lot performed within specifications at this and other customer sites; the qc recovery data do not show any hint of a general reagent issue; a search in the sales force did not reveal any other similar complaints; only single kit affected (an isolated and very rare failure); an out-of-range qc hinted the issue; there was no serious injury or safety impact reported in the case due to the single kit issue.

• 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: 15334969
• MDR Text Key: 305609070
• Report Number: 1823260-2022-02681
• Device Sequence Number: 1
• Product Code: MRG
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 12/16/2022

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: 12/31/2022
• Device Catalogue Number: 09038078190
• Device Lot Number: 62230400
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/09/2022
• Initial Date FDA Received: 09/01/2022
• Supplement Dates Manufacturer Received: 11/23/2022
• Supplement Dates FDA Received: 12/16/2022
• 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