MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS RUBELLA IGG; ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA

Catalog Number 04618793190

Device Problem High Test Results (2457)

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

Event Date 09/05/2023

Event Type  malfunction  

Event Description

The initial reporter questioned a discrepant positive result for 1 patient sample tested for elecsys rubella igg (rubella igg) on a cobas e 411 analyzer (rack system) compared to a competitor method.The result from the e411 analyzer was 35.23 iu/ml (positive).The sample was tested at a different laboratory using a competitor method where the rubella igg result was negative.

Manufacturer Narrative

The e411 analyzer serial number was (b)(6).The competitor method is abbott.Calibration was last performed on (b)(6) 2023 with acceptable results, however, the customer may not be following the recommendations for calibration frequency per the product labeling.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 qc data provided shows results for a level 1 control material that expired in apr-2023.The results were acceptable, however, it is not clear on what date the controls were run.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 pre-analytical information provided was acceptable.The sample was received for investigation.The sample was tested with rubella igg reagent lot 707955 and rubella igm reagent lot 707966 on a cobas e411 analyzer.The customer¿s rubella igg result was reproduced during the investigation (39.75 iu/ml).The rubella igm result was 0.244 coi (negative).The investigation is ongoing.

Manufacturer Narrative

The sample underwent further investigation by mikrogen blot and an in-house neutralization method.The mikrogen blot result was negative with a small band for the e1 antigen-band potentially showing the presence of low-level anti-e1 antibodies.The neutralization method results show the presence of specific anti-rubella igg antibodies.Based on the investigation results, the elecsys rubella igg result was determined to be correctly positive.The investigation did not identify a product problem.

• Brand Name: ELECSYS RUBELLA IGG
• Type of Device: ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA
• 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: 17968897
• MDR Text Key: 326086978
• Report Number: 1823260-2023-03361
• Device Sequence Number: 1
• Product Code: LFX
• Combination Product (y/n): Y
• Reporter Country Code: IT
• PMA/PMN Number: K072617
• 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: 11/22/2023

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 Expiration Date: 02/29/2024
• Device Catalogue Number: 04618793190
• Device Lot Number: 707955
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2023
• Initial Date FDA Received: 10/19/2023
• Supplement Dates Manufacturer Received: 11/14/2023
• Supplement Dates FDA Received: 11/22/2023
• 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 Age: 34 YR
• Patient Sex: Female