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 09/10/2021

Event Type  malfunction  

Manufacturer Narrative

Na.

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with the elecsys rubella igg immunoassay on a cobas e 411 immunoassay analyzer.The sample results were reported outside of the laboratory.The sample initially resulted in a rubella igg value of 38.48 iu/ml (reactive).The sample was repeated, resulting in a value of 38.42 iu/ml (reactive).Another sample collected from the patient at a second site and tested using an unknown method, resulted in a negative rubella igg result.The original sample was repeated on (b)(6) 2021 using the magrumi-nibe (clia) rubella igg method, resulting in a value of 0.747 iu/ml (negative).The original sample was repeated on the e411 analyzer on (b)(6) 2021, resulting in a rubella igg value of 37.08 iu/ml (reactive).The serial number of the e411 analyzer is (b)(4).

Manufacturer Narrative

A sample from the patient was provided for investigation and the results obtained by the customer could be reproduced.

Manufacturer Narrative

Calibration signals were within expected ranges and controls showed good results, however, the provided data indicates the customer does not frequently calibrate or run controls.The customer uses 13x100 mm.Tubes but does not use the required rack adapters for 13 x 100 mm.Tubes.Further investigations of the provided patient sample confirm the sample to be correctly reactive for elecsys rubella igg.A positive result obtained using the mikrogen recomblot method provides evidence for the presence of anti-rubella antibodies in the sample.

• 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: 12583813
• MDR Text Key: 275225951
• Report Number: 1823260-2021-02917
• Device Sequence Number: 1
• Product Code: LFX
• Combination Product (y/n): N
• 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,Followup
• Report Date: 03/18/2022

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: 10/31/2021
• Device Model Number: RUBELLA IGG
• Device Catalogue Number: 04618793190
• Device Lot Number: 51459501
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/16/2021
• Initial Date FDA Received: 10/06/2021
• Supplement Dates Manufacturer Received: 11/03/2021; 02/24/2022
• Supplement Dates FDA Received: 11/23/2021; 03/19/2022
• 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
• Patient Sex: Female