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 12/31/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The investigation is ongoing.

Event Description

The initial reporter received questionable elecsys rubella igg immunoassay for one patient tested on a cobas 6000 e 601 module compared to an abbott analyzer.The patient was vaccinated on (b)(6) 2020.On (b)(6) 2020, the patient had two samples collected at the same time.For one sample, the customer performed rubella igg testing on an e 601 module, and the patient's result was 5.88 iu/ml non-reactive.The customer sent the other sample to another facility with abbott methodology, and the patient's rubella igg result was 12.7 iu/ml positive.The patient's rubella igg results from (b)(6) 2020 were reported outside the laboratory.The doctor has questioned the discrepant results between the two methodologies used for testing.On (b)(6) 2021, the customer performed repeat testing on one of the samples collected on (b)(6) 2020.The patient's rubella igg result on a different elecsys analyzer was 6.62 iu/ml non-reactive.On (b)(6) 2021, the customer performed repeat testing with the same sample that was tested with abbott methodology.At 10:37, the patient's result on the e 601 module was 5.48 iu/ml non-reactive.At 10:46, the patient's result on a different elecsys analyzer was 6.38 iu/ml non-reactive.The customer confirmed qc was acceptable prior to patient testing on (b)(6) 2020 and (b)(6) 2021.The e 601 serial number was (b)(4).The serial number and specific elecsys analyzer used for repeat testing on (b)(6) 2020 and (b)(6) 2020 was requested but not provided.

Manufacturer Narrative

The customer's calibration and qc recovery were found to be ok.Based on the available data, a general reagent issue could be excluded.The investigation determined the difference in results between the roche assay and the competitor was due to differences in assay formats and raw materials used between the different assay methods.The investigation did not identify a product problem.

• 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: 11214082
• MDR Text Key: 262956086
• Report Number: 1823260-2021-00231
• 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: 03/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2021
• 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: 46645400
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: RUBELLA VACCINE
• Patient Age: 41 YR