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

Catalog Number 09038078190

Device Problem High Test Results (2457)

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

Event Date 11/13/2023

Event Type  malfunction  

Event Description

There was an allegation of questionable elecsys vitamin d total iii results for 43 patient samples on a cobas e411 module.Please refer to attachment (b)(4).For patient results.The repeated results were obtained using a new reagent pack.

Manufacturer Narrative

The analyzer serial number is (b)(6).The field service representative checked all of the tubing connections and syringes.A cell replacement had been performed in january 2023.He checked the sample and sipper liquid level detection and he performed sample and sipper primes and discovered the sipper probe was dripping after the prime.He removed and cleaned the part and the dripping stopped.He replaced the sv2 part and sipper probe, adjusted the probe and performed tests with acceptable results.The measuring cell and s/r probe were replaced.He performed additional checks and tests with acceptable results.The customer performed an assay calibration and a precision check.The investigation is ongoing.

Manufacturer Narrative

Questionable elecsys vitamin d total iii results for 7 patient samples were provided.Please refer to the patient results in the attachment "cn-1009577(2)".The questionable results were initially reported outside of the laboratory but were amended.The field service representative fitted a new bead mixer paddle and the speed was adjusted.He fitted a 6-month kit.A lot calibration was performed on a new vitamin d reagent pack.Qc was acceptable.The investigation is ongoing.

Manufacturer Narrative

It was reported that a pipe burst and squirted water onto the analyzer.The customer requested that an engineer check it before turning it back on.The field service representative removed the covers and inspected the analyzer.He observed some watermarks on the printed circuit board (pcb) but found it still functioning correctly.He observed that water was still in the tray and reagent compartment but had dried.He performed tests that showed the analyzer was working within specification.It was reported that the customer observed issues with fluctuating signals and qc.A new reagent lot was calibrated and it was noted there was some foam on the reagents.The qc was out of range.After the bead mixer was adjusted, no foam was observed on the reagents.It was noted the pretempering was performed for 30-60 minutes and rack adapters were not in use for all racks.It is recommended to increase the pretempering time for reagent handling.The customer freezes primary tubes, which is not recommended and increases a risk for issues with sample quality/sample pipetting and results.It was noted that the air conditioner was very close to the analyzer.Installing the instrument close to the air conditioner should be avoided due to possible emi (electromagnetic interference) or on the way of the air conditioner air flows due to possible changes in the air humidity that may affect liquid level detection system.The customer refused to relocate the analyzer.Another service visit occurred.A field service representative performed precision studies under controlled conditions (the air conditioner was switched off and the reagent was pretempered 1 hour).Any outstanding maintenance was performed by the field service representative (daily maintenance, pinch valve tubing replacement, and liquid flow cleaning).The calibration signals were within expected ranges and the precision test was acceptable.The reagent kit was checked after the runs as the remaining determination was 10: bubbles were observed on the surface of the bead compartment of the reagent pack.The remaining determinations/shots in the reagent pack were used to assess roche qc performance at the end of the reagent pack, which were within specification.A sample liquid level detection malfunction was observed during movement and sample volume insufficient or clot pip.Alarms were found in the alarm trace, which may be linked to a sample handling issue.The instrument check was within specifications.Based on the available data, information, and service visits, there are major hints for local issues as root cause (sample handling/ improper preanalytics, reagent handling, general problems with the instrument and work processes).Although the most recent instrument checks were within the specs, instrument-related issues cannot be excluded.Additionally, wetting of the pcb occurred.Due to this fact, it is not possible to guarantee instrument performance.A generic reagent issue is not evident.

• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18290883
• MDR Text Key: 330818006
• Report Number: 1823260-2023-03899
• Device Sequence Number: 1
• Product Code: MRG
• Combination Product (y/n): Y
• Reporter Country Code: UK
• 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
• Report Date: 05/03/2024

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: 743431
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/14/2023
• Initial Date FDA Received: 12/08/2023
• Supplement Dates Manufacturer Received: 01/09/2024; 04/08/2024
• Supplement Dates FDA Received: 01/29/2024; 05/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1