MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS ANTI-HCV II; ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS

Catalog Number	07026889190
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the customer's cobas e 801 analytical unit is (b)(6).The patient sample was requested for investigation.The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable elecsys anti-hcv ii results from two samples from the same patient tested on the cobas e 801 analytical unit.On (b)(6) 2023, the initial result of the initial sample from the e 801 was"non-reactive" with a 0.0504 cut-off index (coi).The patient had a previous reactive result ("hcv = 12.13", in 2021) so they sent the initial patient sample to a support laboratory that uses an abbott analyzer with chemiluminescent microparticle immunoassays (cmia) methodology.On (b)(6) 2023, the first repeat result of the initial patient sample from the support laboratory was "reactive" with a 7.9 coi.On (b)(6) 2023, the second repeat result of the recentrifuged initial patient sample from the e 801 was"non-reactive" with a 0.0481 coi.On (b)(6) 2023, the result of a new patient sample from the e 801 was "non-reactive" with a 0.06 coi.
Additional Manufacturer Narrative
On 23-oct-2023, the confirmatory test result using the 3rd immunoblot generation test for hepatitis c virus antibodies was "non-reactive".The elecsys anti-hcv ii result was confirmed.Based on the information provided, the cause of the event could not be determined.The investigation did not identify a product problem.

• Brand Name: ELECSYS ANTI-HCV II
• Common Device Name: ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS
• 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: 18085058
• Report Number: 1823260-2023-03537
• Device Sequence Number: 7729035
• Product Code: MZO
• UDI-Device Identifier: 04015630939947
• UDI-Public: 04015630939947
• Combination Product (Y/N): Y
• Initial Reporter Country: BR
• PMA/510(K) Number: P140021
• 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): 12/07/2023

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: 07026889190
• Device Lot Number: 682580
• 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: 10/13/2023
• Supplement Date Received by Manufacturer: 11/15/2023
• Initial Report FDA Received Date: 11/07/2023
• Supplement Report FDA Received Date: 12/07/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: B-COMPLEX; GALANTAMINE; LEVOTHYROXINE; NICOTINE; VALPROIC ACID
• Patient Sex: Unknown