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 Consequences Or Impact To Patient (2199)

Event Date 09/20/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The sample was requested for investigation.

Event Description

The initial reporter complained of false positive results for 1 patient sample tested for elecsys rubella igg immunoassay (rubella igg) on a cobas 6000 e 601 module compared to the abbott method.The result from the e601 module was 217.3 ui/ml (positive).The result from the abbott method was 2.8 ui/ml (negative).The e601 module serial number was (b)(4).

Manufacturer Narrative

The customer returned one sample for investigation.The sample was tested using the mikrogen recomblot rublella igg assay.The sample was reactive for the e1 band.The neutralization assay was successful.The investigation determined the results were correctly positive for elecysys rubella igg.Rubella igg is performing as specified.

• 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: 9271364
• MDR Text Key: 204205889
• Report Number: 1823260-2019-03944
• Device Sequence Number: 1
• Product Code: LFX
• 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: 01/03/2020

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 Model Number: RUBELLA IGG
• Device Catalogue Number: 04618793190
• Device Lot Number: 403577
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/11/2019
• Initial Date FDA Received: 11/04/2019
• Supplement Dates Manufacturer Received: 10/11/2019
• Supplement Dates FDA Received: 01/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 26 YR