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 02/22/2023

Event Type  malfunction  

Event 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).

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.

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
• 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: 16666635
• MDR Text Key: 312862334
• Report Number: 1823260-2023-01083
• Device Sequence Number: 1
• Product Code: LFX
• UDI-Device Identifier: 04015630940240
• UDI-Public: 04015630940240
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 03/10/2023
• Initial Date FDA Received: 04/03/2023
• Supplement Dates Manufacturer Received: 06/15/2023
• Supplement Dates FDA Received: 07/13/2023
• 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