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

Catalog Number	07027770190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer's serial number is (b)(6).The calibration and qc were acceptable.The sample from 15-jul-2024 and the sample from 26-aug-2024 were returned for investigation.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys rubella igg results for 1 patient on a cobas 8000 e 801 module.The patient's elecsys rubella igg result was 6.95 iu/ml (non-reactive).This result was considered to be a false negative.The sample was tested using the mikrogen rubella igg method and the anti-e1 reactivity was detected and the patient was considered immune.
Additional Manufacturer Narrative
The customer's non-reactive elecsys rubella igg results were reproduced.It is unknown which sample date each sample belongs to.Investigation results from the sample returned with a transparent cap: the elecsys rubella igg result was 7.7 iu/ml (non-reactive).The elecsys rubella igm result was 0.229 coi (non-reactive).Investigation results from the sample returned with a red cap: the elecsys rubella igg result was 7.26 iu/ml (non-reactive).The elecsys rubella igm result was 0.228 coi (non-reactive).
Additional Manufacturer Narrative
The customer¿s negative elecsys rubella igg result for the investigated patient sample was reproduced during the investigation.The clearly positive mikrogen blot result, the positive results in the platelia rubella igg assay, and the enhanced, though negative result in the elecsys rubella igg assay indicate the presence of anti-rubella igg antibodies.Overall, the investigation found the samples to be very likely positive for rubella igg and the elecsys rubella igg assay is likely false negative.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: 20352681
• Report Number: 1823260-2024-02849
• Device Sequence Number: 7926664
• Product Code: LFX
• UDI-Device Identifier: 04015630940240
• UDI-Public: 04015630940240
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 12/23/2024

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: 03/31/2025
• Device Catalogue Number: 07027770190
• Device Lot Number: 78697601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/09/2024
• Supplement Date Received by Manufacturer: 10/04/2024; 12/09/2024
• Initial Report FDA Received Date: 10/02/2024
• Supplement Report FDA Received Date: 10/30/2024; 12/23/2024
• 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: 20 YR
• Patient Sex: Female