MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS VITAMIN B12 II; RADIOASSAY, VITAMIN B12

Model Number B12 G2

Device Problem Low Test Results (2458)

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

Event Date 07/05/2023

Event Type  malfunction  

Manufacturer Narrative

The e411 analyzer serial number was (b)(6).Instrument performance testing was acceptable.The customer replaced the reagent and performed a new calibration.The customer had no further issues.The investigation is ongoing.

Event Description

Roche diagnostics received an allegation of three questionable elecsys vitamine b12 g2 results from the cobas e 411 immunoassay analyzer.Patient sample 01 initial result was 187 pg/ml and the rerun in another analyzer was 269 pg/ml.Patient sample 02 initial result was 124 pg/ml and the rerun in another analyzer was 222 pg/ml.Patient sample 03 initial result was 149 pg/ml and the rerun in another analyzer was 287 pg/ml.The questionable result was not reported outside of the laboratory.

Manufacturer Narrative

The reagent pack used for the questionable results was first registered on the analyzer on 26-jun-2023 and no new calibration was performed.The customer had performed a lot calibration with a different reagent pack on (b)(6) 2023.The customer did not follow the reccomendations for calibration frequency.Product labeling states: "renewed calibration is recommended as follows: after 1 month (28 days) when using the same reagent lot.After 7 days (when using the same reagent kit on the analyzer).As required: e.G.Quality control findings outside the defined limits." the customer did not perform qc on the day of the event.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." based on the information provided, the specific cause of the event could not be determined.A general reagent kit or lot issue is not suspected, as the qc with the relevant kit was acceptable on the date the kit was registered, and another kit from the same reagent lot performed well.The investigation determined the event was consistent with a use error at the customer site.

• Brand Name: ELECSYS VITAMIN B12 II
• Type of Device: RADIOASSAY, VITAMIN B12
• 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: 17376144
• MDR Text Key: 320485659
• Report Number: 1823260-2023-02416
• Device Sequence Number: 1
• Product Code: CDD
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: K060755
• 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: 09/29/2023

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 Model Number: B12 G2
• Device Catalogue Number: 07212771190
• Device Lot Number: 70733100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/05/2023
• Initial Date FDA Received: 07/24/2023
• Supplement Dates Manufacturer Received: 09/28/2023
• Supplement Dates FDA Received: 09/29/2023
• 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