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

Model Number RUBELLA IGG

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/23/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Phone number was provided as (b)(6).

Event Description

The initial reporter stated they received false negative results 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 was initially tested using the elecsys rubella igg immunoassay, resulting with a value of 8.16 iu/ml (non-reactive).The sample was repeated on 28-sep-2020 using the elecsys rubella igg immunoassay, resulting with a value of 7.63 iu/ml (non-reactive).The sample was tested using a rubella igg elisa assay manufactured by (b)(4), resulting with a value of 69 iu/ml (positive).The sample was also tested with an unknown chemiluminescence method and the rubella igg result is always positive.The serial number of the e 601 analyzer is (b)(4).

Manufacturer Narrative

The last calibration was performed on (b)(6) 2020.The signals recovered above expected ranges.The quality controls were within specified ranges, but the customer only ran one level of control on (b)(6) 2020 and (b)(6)-2020.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: 10703765
• MDR Text Key: 213687629
• Report Number: 1823260-2020-02592
• 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: 11/05/2020

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: 443879
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/30/2020
• Initial Date FDA Received: 10/20/2020
• Supplement Dates Manufacturer Received: 09/30/2020
• Supplement Dates FDA Received: 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1