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

Catalog Number	07027770190
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The e402 analyzer serial number was (b)(6).Sample material was requested for investigation.
Event or Problem Description
The initial reporter questioned positive results for 9 patient samples tested for elecsys rubella igg (rubella igg) on a cobas e 402 analytical unit compared to a cobas e801 analyzer at another laboratory.On (b)(6) 2024 patient 1 result from the e402 analyzer was 21 iu/ml (positive).The result from the e801 analyzer was 7.6 iu/ml (negative).On (b)(6) 2024 patient 2 result from the e402 analyzer was 15.3 iu/ml (positive).The result from the e801 analyzer was 6.1 iu/ml (negative).On (b)(6) 2024 patient 3 result from the e402 analyzer was 60.7 iu/ml (positive).The result from the e801 analyzer was 5.6 iu/ml (negative).On (b)(6) 2024 patient 4 result from the e402 analyzer was 14 iu/ml (positive).The result from the e801 analyzer was 4.8 iu/ml (negative).On (b)(6) 2024 patient 5 result from the e402 analyzer was 21.7 iu/ml (positive).The result from the e801 analyzer was 6.9 iu/ml (negative).On (b)(6) 2024 patient 6 result from the e402 analyzer was 40.2 iu/ml (positive).The result from the e801 analyzer was 3.5 iu/ml (negative).On (b)(6) 2024 patient 7 result from the e402 analyzer was 45.3 iu/ml (positive).The result from the e801 analyzer was 7.4 iu/ml (negative).On (b)(6) 2024 patient 8 result from the e402 analyzer was 16.2 iu/ml (positive).The result from the e801 analyzer was 4.4 iu/ml (negative).On (b)(6) 2024 patient 9 result from the e402 analyzer was 17.2 iu/ml (positive).The result from the e801 analyzer was 7.7 iu/ml (negative).
Additional Manufacturer Narrative
The customer collected 17 new samples, which were submitted for investigation.These were not the same samples from the original complaint.The 17 new patient samples were tested for rubella igg on a cobas e 402 analytical unit and a cobas e801 analyzer used at the investigation site.The customer's reagent lot (815316) and an additional reagent lot (856046) were used.All of the rubella igg results from both analyzers and reagent lots were positive.The investigation did not reproduce the customer's observation.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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 21881700
• Report Number: 1823260-2025-01224
• Device Sequence Number: 8631456
• 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): 07/31/2025

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 Expiration Date: 07/31/2025
• Device Catalogue Number: 07027770190
• Device Lot Number: 815316
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/01/2025
• Supplement Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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