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 12/30/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter stated they received a discrepant result for one patient sample tested with the elecsys rubella igg immunoassay on a cobas 6000 e 601 module.No incorrect results were reported outside of the laboratory.The sample resulted with a rubella igg value of 15.2 ui/ml (positive) when tested on the e 601 analyzer.The sample was repeated on a beckman dxi analyzer, resulting with a value of < 10.0 ui/ml (negative).The e 601 analyzer serial number is (b)(4).

Manufacturer Narrative

The customer measured the patient sample again using new elecsys rubella igg reagent lot 514595 (expiration date unknown), resulting with a value of 15 ui/ml (positive).

Manufacturer Narrative

Calibration signals from the calibration performed on (b)(6)-2020 were lower than expected.Quality controls recovered within range.There was no remaining patient sample available for investigation.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: 11169284
• MDR Text Key: 227893536
• Report Number: 1823260-2021-00166
• 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,Followup
• Report Date: 04/27/2021

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: 02/28/2021
• Device Model Number: RUBELLA IGG
• Device Catalogue Number: 04618793190
• Device Lot Number: 466454
• 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; 01/05/2021
• Supplement Dates FDA Received: 03/17/2021; 04/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 35 YR