MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS RUBELLA IGG IMMUNOASSAY; 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	08/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sample from the patient was requested for investigation.
Event or Problem Description
There was an allegation of questionable rubella igg elecsys results from cobas e 801 module serial number (b)(4).From the first sample from the patient, the rubella igg result was 53.5 ui/ml (positive).The result from another laboratory using vidas biomérieux was negative.On (b)(6) 2021, a second sample drawn from the patient at the same time as the first sample was tested.The rubella igg result was 54.2 ui/ml (positive).The result from another laboratory was negative.It was not known if the questionable results were reported outside of the laboratory.
Additional Manufacturer Narrative
Sample from the patient was received for investigation and the positive results for elecsys rubella igg were reproduced.The sample was tested with the elecsys rubella igg assay, as well as the platelia rubella igg, recomblot rubella igg, and neutralization assay all with positive results.Based on the overall results from the investigation, the positive result was believed to be correct for the sample.

• Brand Name: ELECSYS RUBELLA IGG IMMUNOASSAY
• Common Device Name: ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 12412743
• Report Number: 1823260-2021-02564
• Device Sequence Number: 4687367
• 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
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2021

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: 02/28/2022
• Device Model Number: RUBELLA IGG
• Device Catalogue Number: 07027770190
• Device Lot Number: 53326901
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/13/2021
• Supplement Date Received by Manufacturer: 09/23/2021
• Initial Report FDA Received Date: 09/02/2021
• Supplement Report FDA Received Date: 09/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 25 YR