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	03/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the e801 analyzer is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with elecsys rubella igg on a cobas e 801 module.The sample resulted in a rubella igg value of 14 iu/ml (reactive) when tested on the e 801 analyzer.The sample was repeated on a vidas instrument, resulting in a negative rubella igg result.
Additional Manufacturer Narrative
The following information in b5 is incorrect: "the initial reporter stated they received discrepant results for one patient sample tested with elecsys rubella igg on a cobas e 801 module.The sample resulted in a rubella igg value of 14 iu/ml (reactive) when tested on the e 801 analyzer.The sample was repeated on a vidas instrument, resulting in a negative rubella igg result." the customer has confirmed the correct b5 information as follows: the initial reporter stated they received discrepant results for one patient sample tested with elecsys rubella igg on a cobas e 801 module.The issue occurred in (b)(6) 2024.The specific date of the event is not known.The sample resulted in a rubella igg value of 15 iu/ml (reactive) when tested on the e 801 analyzer.The sample was repeated on a vidas instrument, resulting in a negative rubella igg result.The following information in b6 is incorrect: "in (b)(6) 2024, the patient had a rubella igg result of 15 iu/ml (reactive)." the customer has confirmed the correct b6 information as follows: on (b)(6) 2024, the patient had a rubella igg result of 14 iu/ml (reactive).The patient sample was tested at another site using the vidas rubella igg and rubella igm method.With the vidas method, the rubella igg result was 6.95 iu/ml (negative) and the rubella igm result was 0.21 index (negative).Additionally, the sample was tested with the mikrogen rubella igg western blot and was positive for e1 antigen.It was concluded that the patient is immunized and a carrier of protective antibodies.Medwatch fields a2, a3, and d4 have been updated.
Additional Manufacturer Narrative
Calibration and controls were acceptable.Elecsys rubella igg reagent lots 786976 and 764061 (expiration = 31-oct-2024) were used by the customer.The investigation did not identify a product issue.The reactive elecsys rubella igg result is in line with the conclusion from the other site that the patient is immunized and a carrier of protective antibodies.

• 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 46250-0457
• MDR Report Key: 19921430
• Report Number: 1823260-2024-02282
• Device Sequence Number: 20733583
• 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): 09/18/2024

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 Catalogue Number: 07027770190
• Device Lot Number: 786976, 764061
• 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: 07/25/2024
• Supplement Date Received by Manufacturer: 07/25/2024; 09/16/2024
• Initial Report FDA Received Date: 08/06/2024
• Supplement Report FDA Received Date: 08/21/2024; 09/18/2024
• 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: 28 YR
• Patient Sex: Female