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

Model Number	RUBELLA IGG
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter questioned positive results for 1 patient sample tested for elecsys rubella igg rubella igg on a cobas e 801 analytical unit.The initial result from the e801 analyzer was 155 iu/ml positive.The repeat on the same analyzer was 174 iu/ml positive.The sample was sent to an external laboratory for testing by the vidas method and the rubella igg result was 9.74 iu/ml negative.It is not known if the questionable positive results were reported outside of the laboratory.The e801 analyzer serial number was (b)(4).
Additional Manufacturer Narrative
The sample was requested for investigation.The sample was received for investigation and tested on an e801 module.The rubella igg result was 135 iu/ml positive.The rubella igm result was 0.238 coi negative.The customer¿s rubella igg results were reproduced.The investigation is ongoing.
Additional Manufacturer Narrative
The patient sample was investigated further.The platelia rubella igg result was positive.The mikrogen recomblot rubella igg result was positive.The sample was tested with a neutralization assay.The sample was neutralizable (positive for specific anti-rubella igg antibodies).Based on the investigation results, the patient sample was determined to be correctly positive for rubella igg.The reagent performed within specification.The investigation did not identify a product problem.

• Brand Name: ELECSYS RUBELLA IGG
• Common Device Name: 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: 16666635
• Report Number: 1823260-2023-01083
• Device Sequence Number: 12416202
• Product Code: LFX
• UDI-Device Identifier: 04015630940240
• UDI-Public: 04015630940240
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K072617
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2023

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
• Operator of Device: Health Professional
• Device Model Number: RUBELLA IGG
• Device Catalogue Number: 07027770190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2023
• Supplement Date Received by Manufacturer: 06/15/2023
• Initial Report FDA Received Date: 04/03/2023
• Supplement Report FDA Received Date: 07/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown