MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS HBSAG CONFIRMATORY TEST; TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)

Catalog Number	09127127190
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the customer's cobas e 801 analytical unit is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter received a questionable hbsag confirmatory elecsys result from one patient sample tested on the cobas e 801 analytical unit.The questionable result was not reported outside of the laboratory.The result of hbsag confirmatory test was "reactive".The patient sample was sent to another laboratory.The hbsag result from the other laboratory was "negative".
Additional Manufacturer Narrative
The investigation reviewed the last calibration performed on (b)(6) 2024; the results were within specifications.The investigation reviewed the qc recovery; the results were within +/- 2 standard deviations (sd).There was no indication of a performance issue with the reagent.The customer stated that the event only occurred with one patient sample.Based on the information provided, the investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS HBSAG CONFIRMATORY TEST
• Common Device Name: TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)
• 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: 18977392
• Report Number: 1823260-2024-00901
• Device Sequence Number: 12270953
• Product Code: LOM
• UDI-Device Identifier: 07613336175293
• UDI-Public: 07613336175293
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P990012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2024

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: 09127127190
• Device Lot Number: ASKU
• 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: 03/04/2024
• Supplement Date Received by Manufacturer: 04/22/2024
• Initial Report FDA Received Date: 03/26/2024
• Supplement Report FDA Received Date: 05/09/2024
• 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