MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS RUBELLA IGG IMMUNOASSAY; ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA

Model Number RUBELLA IGG

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/30/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter stated they received discrepant results for two patient samples tested with the elecsys rubella igg immunoassay on a cobas 6000 e 601 module.No incorrect results were reported outside of the laboratory.The first patient sample resulted with a rubella igg value of 0.8 ui/ml (negative).The patient is known to be positive based on previous results.The sample was sent for testing on a vidas analyzer, resulting with a negative value.The second patient sample resulted with a rubella igg value of 3.3 ui/ml (negative) on (b)(6) 2020.This sample was tested on a vidas analyzer, resulting with a value of 54 (no unit provided, positive).This sample was also tested on a beckman analyzer, resulting with a value of 25.5 ui/ml (positive).The e 601 analyzer serial number is (b)(4).

Manufacturer Narrative

The customer measured the first patient sample using new elecsys rubella igg reagent lot number 514595 (expiration date unknown), resulting with a value of 1.6 ui/ml (negative).The customer's calibration signals for reagent lot 443879 were lower than expected.Controls recovered within range between (b)(6) 2020.No sample material was available for investigation of the second patient.A general reagent issue could most likely be excluded.The investigation could not identify a product problem.The cause of the event could not be determined.

• 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: 11169277
• MDR Text Key: 249392162
• Report Number: 1823260-2021-00165
• 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: 03/18/2021

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 Model Number: RUBELLA IGG
• Device Catalogue Number: 04618793190
• Device Lot Number: 443879
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/05/2021
• Initial Date FDA Received: 01/14/2021
• Supplement Dates Manufacturer Received: 01/05/2021
• Supplement Dates FDA Received: 03/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 41 YR