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 07/20/2022

Event Type  malfunction  

Event Description

There was an allegation of a questionable rubella igg elecsys from cobas e 801 module serial number 1785-06.The result was 42 ui/l (reactive).The result by vidas method was 7 ui/ml (non-reactive).The result by abbott alinity was 4.7 ui/ml (non-reactive) the result by diasorin liaison was (non-reactive).The questionable result was not reported outside of the laboratory.

Manufacturer Narrative

The investigation is ongoing.

Manufacturer Narrative

Further testing of the patient sample found the platelia igg results were 9.04 and 9.99 iu/ml(negative), the mikrogen blot rubella igg result was reactive, and the neutralization assay showed evidence for anti-rubella igg antibodies.As the customer's positive result was reproducible, the result was deemed correct for the sample.As the customer's calibration and qc were within the acceptable range, there was no issue found with the reagent.D4 - expiration date was updated.

Manufacturer Narrative

The sample was submitted for investigation and the elecsys rubella igg result was 35.6 iu/ml (reactive).The elecsys rubella igm result was 0.296 coi (non-reactive).The investigation is ongoing.

• 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: 15224974
• MDR Text Key: 303433856
• Report Number: 1823260-2022-02427
• 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,Followup
• Report Date: 11/07/2022

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: 01/31/2023
• Device Model Number: RUBELLA IGG
• Device Catalogue Number: 07027770190
• Device Lot Number: 61718900
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/20/2022
• Initial Date FDA Received: 08/15/2022
• Supplement Dates Manufacturer Received: 09/26/2022; 10/24/2022
• Supplement Dates FDA Received: 10/19/2022; 11/07/2022
• 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
• Patient Sex: Female