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	03/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys rubella igg immunoassay results for 4 patient samples on a cobas pure e 402 analytical unit.For patient 1, the initial rubella igg result was 63.6 iu/ml, interpreted as positive.The sample was sent to a reference laboratory and the result was negative.For patient 2, the initial rubella igg result was 50.1 iu/ml, interpreted as positive.The sample was sent to a reference laboratory and the result was negative.For patient 3, the initial rubella igg result was 23.2 iu/ml, interpreted as positive.The sample was sent to a reference laboratory and the result was negative.For patient 4, the initial rubella igg result was 52.4 iu/ml, interpreted as positive.The sample was sent to a reference laboratory and the result was negative.No questionable results were reported outside of the laboratory.The testing method used by the reference laboratory was requested but not provided.The analyzer serial number is (b)(6).
Additional Manufacturer Narrative
Calibration was last performed on (b)(6) 2023 and on (b)(6) 2023.Calibration data was acceptable.The qc recovery data provided was acceptable.The patient samples were submitted for investigation.Patient 1's sample leaked during transport and was unable to be tested.Elecsys rubella igg testing was carried out and all four samples gave reactive results.Elecsys rubella igm testing was carried out and all four samples gave non-reactive results.Platelia rubella igg testing was carried out and sample 2 gave a negative result while samples 3, 4, and 5 gave positive results.Mikrogen recomblot rubella igg testing was carried out and sample 2 gave an indeterminate result while samples 3, 4, and 5 gave positive results.All four samples were able to be neutralized.Samples 3, 4, and 5 were able to be confirmed rubella igg positive.Sample 2's enhanced platelia result, three week bands in the mikrogen testing, and successful neutralization are consistent with the initial positive rubella igg result.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: 17073250
• Report Number: 1823260-2023-01878
• Device Sequence Number: 17852911
• Product Code: LFX
• UDI-Device Identifier: 04015630940240
• UDI-Public: 04015630940240
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 09/07/2023

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: 637180
• 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: 05/11/2023
• Supplement Date Received by Manufacturer: 08/22/2023
• Initial Report FDA Received Date: 06/06/2023
• Supplement Report FDA Received Date: 09/07/2023
• 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