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

Model Number	RUBELLA IGG
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of a questionable rubella igg elecsys from cobas e 801 module serial number 1785-06.The result was 42 ui/l (reactive).The result by vidas method was 7 ui/ml (non-reactive).The result by abbott alinity was 4.7 ui/ml (non-reactive) the result by diasorin liaison was (non-reactive).The questionable result was not reported outside of the laboratory.
Additional Manufacturer Narrative
The investigation is ongoing.
Additional Manufacturer Narrative
Further testing of the patient sample found the platelia igg results were 9.04 and 9.99 iu/ml(negative), the mikrogen blot rubella igg result was reactive, and the neutralization assay showed evidence for anti-rubella igg antibodies.As the customer's positive result was reproducible, the result was deemed correct for the sample.As the customer's calibration and qc were within the acceptable range, there was no issue found with the reagent.D4 - expiration date was updated.
Additional Manufacturer Narrative
The sample was submitted for investigation and the elecsys rubella igg result was 35.6 iu/ml (reactive).The elecsys rubella igm result was 0.296 coi (non-reactive).The investigation is ongoing.

• Brand Name: ELECSYS RUBELLA IGG
• Common Device Name: 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15224974
• Report Number: 1823260-2022-02427
• Device Sequence Number: 5566563
• Product Code: LFX
• UDI-Device Identifier: 04015630940240
• UDI-Public: 04015630940240
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K072617
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/07/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: RUBELLA IGG
• Device Catalogue Number: 07027770190
• Device Lot Number: 61718900
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2022
• Supplement Date Received by Manufacturer: 09/26/2022; 10/24/2022
• Initial Report FDA Received Date: 08/15/2022
• Supplement Report FDA Received Date: 10/19/2022; 11/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Female