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 01/19/2021

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The customer provided the samples for investigation.For patient 1, the investigation's results are below: rubella igg results: 60.7 iu/ml reactive and 55.2 iu/ml reactive, rubella igm: non-reactive for both samples.For patient 2, the investigation's results are below: rubella igg result: 15.2 iu/ml reactive, rub igm: non-reactive.The investigation confirmed the customer's results.The investigation is ongoing.Unique device identifier (udi): (b)(4).

Event Description

The initial reporter received questionable elecsys rubella igg immunoassay results for two patients tested on a cobas 8000 e 801 module serial number (b)(4).The initial rubella igg results were reported outside the laboratory.The customer performed repeat testing with the cobas 8000 e 801 module and an abbott analyzer for confirmation.On (b)(6) 2021 and at 13:35, patient 1's elecsys rubella igg result was 60.1 iu/ml reactive.At 14:27, patient 1's repeat elecsys rubella igg result was 61.0 iu/ml reactive.At 17:43, patient 1's rubella igg result was 5.0 iu/ml grayzone with an abbott architect.On (b)(6) 2021 and at 14:22, patient 2's elecsys rubella igg result was 15.5 iu/ml reactive.Patient 2's rubella igg result at a different laboratory with an unknown laboratory methodology was 15.5 iu/ml grayzone.

Manufacturer Narrative

The customer's calibration and qc data were acceptable.The customer's sample pre-analytical data was ok.The samples were further investigated with the platelia rubella igg assay, the mikrogen recomblot rubella igg, and by neutralization.Mikrogen recom blot rubella igg results: patient 1: reactive patient 2: reactive the mikrogen recomblot rubella igg was determined positive.Platelia rubella igg resuts: patient 1: reactive patient 2: reactive the platelia rubella igg assay was determined positive.Neutralization results: patient 1: successful neutralization patient 2: neutralization was not successful for patient 1, the successful neutralization result confirmed the presence of anti-rubella igg antibodies.For patient 2, the neutralization was not successful due to the low signal level before neutralization.Based on the positivity in the platelia rubella igg assay and the reactivities obtained in the mikrogen recomblot rubella igg, the samples are regarded as positive for rubella igg.Due to the supportive data obtained with the platelia rubella igg, the mikrogen recomblot rubella igg, and the neutralization experiment these three samples are regarded correctly positive in the elecsys rubella igg.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: 11365148
• MDR Text Key: 233891385
• Report Number: 1823260-2021-00537
• 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: 04/05/2021

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: 06/30/2021
• Device Model Number: RUBELLA IGG
• Device Catalogue Number: 07027770190
• Device Lot Number: 48859001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/27/2021
• Initial Date FDA Received: 02/23/2021
• Supplement Dates Manufacturer Received: 01/27/2021
• Supplement Dates FDA Received: 04/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1