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	11/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys rubella igg immunoassay results for 3 patient samples on a cobas e 801 analytical unit compared to a siemens assay.For patient 1, the elecsys rubella igg result was 17.2 iu/ml, interpreted as positive.The siemens assay result was negative.For patient 2, the elecsys rubella igg result was 91.9 iu/ml, interpreted as positive.The siemens assay result was negative.For patient 3, the elecsys rubella igg result was 27.2 iu/ml, interpreted as positive.The siemens assay result was negative.The initial elecsys assay results were reported outside of the laboratory.The e801 analyzer serial number is (b)(4).
Additional Manufacturer Narrative
The patient samples were provided for investigation.The investigation obtained reactive results for rubella igg for all three samples.The samples were also tested for rubella igm and all three samples were non-reactive.The investigation is ongoing.
Additional Manufacturer Narrative
Calibration was last performed on (b)(6) 2023.The investigation determined that the customer's results were reproducible and the patient samples provided were correctly positive for rubella igg.The reagent performed within specification.

• 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: 15987899
• Report Number: 1823260-2022-04027
• Device Sequence Number: 6090033
• Product Code: LFX
• UDI-Device Identifier: 04015630940240
• UDI-Public: 04015630940240
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K072617
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• 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): 04/25/2023

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
• Operator of Device: Health Professional
• Device Model Number: RUBELLA IGG
• Device Catalogue Number: 07027770190
• Device Lot Number: 637180
• 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: 11/23/2022
• Supplement Date Received by Manufacturer: 12/23/2022; 04/03/2023
• Initial Report FDA Received Date: 12/15/2022
• Supplement Report FDA Received Date: 03/07/2023; 04/25/2023
• 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: Unknown