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 09/01/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The samples were submitted for investigation.The customer's positive rubella igg results were confirmed.The investigation is ongoing.

Event Description

The initial reporter complained of discrepant high results for 7 patient samples tested for elecsys rubella igg immunoassay (rubella igg) on a cobas 6000 e 601 module compared to the abbott alinity method.Refer to attached data for patient results.The e601 module serial number was (b)(4).

Manufacturer Narrative

The samples were investigated further.The customer's rubella igg results were further reproduced and confirmed to be correctly positive for all samples.The mikrogen recomblot rubella igg as well as the neutralization assay confirmed the presence of specific anti-rubella igg antibodies.The investigation determined the assay performs within specification.A product problem was not found.

• 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: 9458309
• MDR Text Key: 206832855
• Report Number: 1823260-2019-04391
• 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: 02/11/2020

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: 40357702
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/12/2019
• Initial Date FDA Received: 12/12/2019
• Supplement Dates Manufacturer Received: 11/12/2019
• Supplement Dates FDA Received: 02/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1