MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS RUBELLA IGG IMMUNOASSAY; 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 08/02/2021

Event Type  malfunction  

Manufacturer Narrative

Sample from the patient was requested for investigation.

Event 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.

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
• Type of Device: ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 12412743
• MDR Text Key: 273010725
• Report Number: 1823260-2021-02564
• Device Sequence Number: 1
• Product Code: LFX
• UDI-Device Identifier: 04015630940240
• UDI-Public: 04015630940240
• Combination Product (y/n): N
• PMA/PMN Number: K072617
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 08/13/2021
• Initial Date FDA Received: 09/02/2021
• Supplement Dates Manufacturer Received: 09/23/2021
• Supplement Dates FDA Received: 09/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 25 YR