MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT ANTI-HCV REAGENT KIT; ASSAY, ENZYME LINKED IMMUNOSORBENT, HEPATITIS C VIRUS

Model Number	1L79-25
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Was this device serviced by a third party? no.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Patient identifier complete entry = (b)(6).All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed a (b)(6) architect anti-hcv result for one patient.The following data was provided (b)(6) is grayzone, (b)(6): sample id (b)(6) initial result, on (b)(6) 2021, was (b)(6), repeat results were (b)(6).There was no impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation for false nonreactive architect anti-hcv results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, and testing of the complaint lot number.Trending review determined no related trend for the issue for the product.Return testing was not completed, as returns were not available.Sensitivity testing was performed using an in-house retained kit of lot 22295be00, stored at the recommended storage condition.All specifications were met indicating that the lot is performing acceptably.Device history record review did not identify any non-conformances or deviations with the likely cause lot and complaint issue.Manufacturing documentation for the likely cause lot was reviewed and did not identify any issues.Labeling was reviewed and sufficiently addresses the customer's issue.Based on the information provided and abbott diagnostics¿ complaint investigation, no systemic issue or deficiency of architect anti-hcv reagent, lot number 22295be00 was identified.This follow up is being submitted to include d8 and h6 information previously submitted using the h10 section in their respective fields.

• Brand Name: ARCHITECT ANTI-HCV REAGENT KIT
• Common Device Name: ASSAY, ENZYME LINKED IMMUNOSORBENT, HEPATITIS C VIRUS
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 11777468
• Report Number: 3002809144-2021-00292
• Device Sequence Number: 19763408
• Product Code: MZO
• UDI-Device Identifier: 00380740001414
• UDI-Public: 00380740001414
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P050042
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2021

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: 10/11/2021
• Device Model Number: 1L79-25
• Device Catalogue Number: 01L79-25
• Device Lot Number: 22295BE00
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/18/2021
• Supplement Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 05/05/2021
• Supplement Report FDA Received Date: 06/29/2021
• 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: ARC I1000SR MOD, 01L86-01, (B)(4); ARC I1000SR MOD, 01L86-01, (B)(4)