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

Model Number RUBELLA IGG

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/23/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.

Event Description

There was an allegation of questionable elecsys rubella igg immunoassay results for 3 patient samples on a cobas e 801 analytical unit compared to a siemens assay.For patient 1, the elecsys rubella igg result was 17.2 iu/ml, interpreted as positive.The siemens assay result was negative.For patient 2, the elecsys rubella igg result was 91.9 iu/ml, interpreted as positive.The siemens assay result was negative.For patient 3, the elecsys rubella igg result was 27.2 iu/ml, interpreted as positive.The siemens assay result was negative.The initial elecsys assay results were reported outside of the laboratory.The e801 analyzer serial number is (b)(4).

Manufacturer Narrative

The patient samples were provided for investigation.The investigation obtained reactive results for rubella igg for all three samples.The samples were also tested for rubella igm and all three samples were non-reactive.The investigation is ongoing.

Manufacturer Narrative

Calibration was last performed on (b)(6) 2023.The investigation determined that the customer's results were reproducible and the patient samples provided were correctly positive for rubella igg.The reagent performed within specification.

• Brand Name: ELECSYS RUBELLA IGG
• Type of Device: ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15987899
• MDR Text Key: 308105697
• Report Number: 1823260-2022-04027
• Device Sequence Number: 1
• Product Code: LFX
• UDI-Device Identifier: 04015630940240
• UDI-Public: 04015630940240
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K072617
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/25/2023

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: 07027770190
• Device Lot Number: 637180
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2022
• Initial Date FDA Received: 12/15/2022
• Supplement Dates Manufacturer Received: 12/23/2022; 04/03/2023
• Supplement Dates FDA Received: 03/07/2023; 04/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1