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

Catalog Number	07026889190
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample from the patient was requested for investigation.The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received questionable values for two samples from the same patient tested with elecsys anti-hcv ii.The first complained sample (sample 3) was tested on two cobas 8000 e 801 module analyzers.The second complained sample (sample 4) was tested on an unknown roche analyzer.The sample results were reported outside of the laboratory.On (b)(6) 2022, a first sample collected from the patient was tested using the abbott alinity hepatitis c method, resulting in a value of 3.83 s/co (reactive).On (b)(6) 2022, a second sample collected from the patient was tested using the abbott real time hcv viral load quantification method, resulting in a value of 5311136 iu/ml (6.72 log).On (b)(6) 2022, a third sample collected from the patient was tested using the elecsys anti-hcv on the first e 801 analyzer, resulting in a value of 0.0439 coi (non reactive).This sample was repeated on a second e 801 analyzer on (b)(6) 2022, resulting in a non-reactive value.On (b)(6) 2022, a fourth sample collected from the patient on (b)(6) 2022 was tested on an unknown roche analyzer on (b)(6) 2022, resulting in a value of 0.045 coi (non reactive).On (b)(6) 2022, a fifth sample collected from the patient was tested with the cobas hcv pcr viral load/hcv pc quantitative kit, resulting in a value of 1400000 iu/ml (7.15 log).On (b)(6) 2022, a sixth sample collected from the patient was tested using the riba anti hcv- immunoblot 3rd generation method, resulting in the following: conclusion: indeterminate core: negative ns3-1: 3+ ns3-2: negative ns4: negative ns5: negative.On (b)(6) 2022, a seventh sample collected from the patient was tested twice on the second e 801 analyzer, resulting in values of 1.27 coi (reactive) and 1.22 coi (reactive).A serial number of the first e 801 analyzer is (b)(4).It was asked, but it is not known what the serial numbers were for the second e 801 analyzer or unknown roche system.Sample 3 was tested using elecsys anti-hcv reagent lot 58750101, with an expiration date of 30-nov-2022.Sample 4 was tested using elecsys anti-hcv reagent lot 587906.The expiration date for this lot was requested, but not provided.
Additional Manufacturer Narrative
The serial numbers of the e 801 analyzers have been confirmed as follows: first e 801 = serial number (b)(6).Second e 801 = serial number (b)(6).No samples from the patient were available for investigation.Calibration and control data were acceptable.The investigation could not identify a product problem.The cause of the event could not be determined.

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15261657
• Report Number: 1823260-2022-02508
• Device Sequence Number: 5887208
• Product Code: MZO
• UDI-Device Identifier: 04015630939947
• UDI-Public: 04015630939947
• Combination Product (Y/N): N
• 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): 09/13/2022

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: 11/30/2022
• Device Catalogue Number: 07026889190
• Device Lot Number: 58750101, 587906
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2022
• Supplement Date Received by Manufacturer: 08/23/2022
• Initial Report FDA Received Date: 08/19/2022
• Supplement Report FDA Received Date: 09/13/2022
• 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 Age: 62 YR
• Patient Sex: Male