MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS RUBELLA IGM; RUBELLA VIRUS IMMUNOGLOBULIN M (IGM) ANTIBODY IVD, KIT, CHEMILUMINESCENT IMMUNOA

Catalog Number	07027796190
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One patient sample was received for investigation.The investigation confirmed the customer's rubella igm result.The investigation reviewed the qc data provided and the results were within specifications.The investigation determined the event was due to a sample-specific discrepancy.Product labeling states "for diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings." the investigation did not identify a product problem.
Additional Manufacturer Narrative
The serial number of the cobas e 801 module is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable rubella igm elecsys results from two samples from the same patient tested on the cobas e 801 module.The reporter was validating the assay and used the patient sample as an internal qc.The patient sample was sent to another laboratory that uses enzyme-linked fluorescence assay (elfa) and chemiluminescence immunoassay (clia) laboratory methods.Sample 1 on (b)(6) 2024: the initial result from the module was 0.746 cut-off index coi (non-reactive).On (b)(6) 2024: the repeat result from the elfa laboratory method was 3.39 index (reactive).The repeat result from the clia laboratory method was 8.04 index (reactive).Sample 2 on (b)(6) 2024: the initial result from the module was 0.740 coi (non-reactive).The repeat result from the elfa laboratory method was 3.60 index (reactive).The repeat result from the clia laboratory method was 8.12 index (reactive).

• Brand Name: ELECSYS RUBELLA IGM
• Common Device Name: RUBELLA VIRUS IMMUNOGLOBULIN M (IGM) ANTIBODY IVD, KIT, CHEMILUMINESCENT IMMUNOA
• 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: 20332493
• Report Number: 1823260-2024-02814
• Device Sequence Number: 7836167
• Product Code: LFX
• UDI-Device Identifier: 04015630940257
• UDI-Public: 04015630940257
• Combination Product (Y/N): Y
• Initial Reporter Country: BR
• PMA/510(K) Number: K092322
• 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): 12/10/2024

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: 09/30/2024
• Device Catalogue Number: 07027796190
• Device Lot Number: 765023
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/03/2024
• Supplement Date Received by Manufacturer: 11/27/2024
• Initial Report FDA Received Date: 09/30/2024
• Supplement Report FDA Received Date: 12/10/2024
• 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 Age: 38 YR
• Patient Sex: Female