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

Model Number RUBELLA IGG

Device Problem High Test Results (2457)

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

Event Date 05/24/2022

Event Type  malfunction  

Event Description

The initial reporter stated they received a false positive result for one patient sample tested with the elecsys rubella igg immunoassay on a cobas 8000 e 602 module (serial number (b)(4)).The sample resulted in a rubella igg value of 24.6 ui/ml (reactive) when tested on the e 602 analyzer and this value was reported outside of the laboratory.The sample was repeated using the diasorin method, resulting in a value of 2 ui/ml (non-reactive).The sample was also tested using the alinity method and the result was negative.

Manufacturer Narrative

A sample from the patient was provided for investigation.Investigations are ongoing.

Manufacturer Narrative

Calibration signals were within expected ranges.Quality control results were within specified ranges.Further investigations of the patient sample determined that it is correctly reactive with the elecsys rubella igg assay.The reagent performed within specifications.

Manufacturer Narrative

Upon initial investigation of the patient sample, the customer's results could be reproduced.

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 14843131
• MDR Text Key: 303062073
• Report Number: 1823260-2022-01894
• Device Sequence Number: 1
• Product Code: LFX
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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,Followup
• Report Date: 08/26/2022

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: 10/31/2022
• Device Model Number: RUBELLA IGG
• Device Catalogue Number: 04618793190
• Device Lot Number: 58677701
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/07/2022
• Initial Date FDA Received: 06/28/2022
• Supplement Dates Manufacturer Received: 06/24/2022; 08/01/2022
• Supplement Dates FDA Received: 07/18/2022; 08/26/2022
• 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