MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT ANTI-HCV

Model Number	1L79-25
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information: no further patient information was provided by the customer.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed a false nonreactive architect anti-hcv result for 1 patient.A different sample from another laboratory was reactive.No impact to patient management was reported.
Additional Manufacturer Narrative
A review of tickets was performed for reagent lot number 07124be00.The ticket search determined that there is normal complaint activity for the likely cause lot.A review of tracking and trending did not identify any trends for the complaint issue.Return testing was not completed as returns were not available.Retained reagent kits of lot number 07124be00 were tested in a sensitivity setup including two sensitivity panels and the positive control on two analyzers.All values met specifications and all results were in the typical range and no false nonreactive results were obtained.Additionally, two commercially available seroconversion panels were tested on one analyzer.The results were compared to architect anti-hcv test results provided by the panel manufacturer.The reagent detected the same bleeds as reactive with comparable s/co values for the seroconversion panels.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.A review of labeling concluded that the issue is sufficiently addressed.Based on the investigation no systemic issue or deficiency of the architect anti-hcv reagent, lot number 07124be00 was identified.

• Brand Name: ARCHITECT ANTI-HCV
• Common Device Name: ANTI-HCV
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 9526965
• Report Number: 3002809144-2019-01094
• Device Sequence Number: 2703061
• Product Code: MZO
• UDI-Device Identifier: 00380740001414
• UDI-Public: 00380740001414
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2020

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: 05/25/2020
• Device Model Number: 1L79-25
• Device Catalogue Number: 01L79-25
• Device Lot Number: 07124BE00
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/18/2019
• Supplement Date Received by Manufacturer: 03/16/2020
• Initial Report FDA Received Date: 12/27/2019
• Supplement Report FDA Received Date: 03/18/2020
• 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: ARCHITECT I1000SR PROCESSING MODULE; ARCHITECT I1000SR PROCESSING MODULE; LIST 01L86-01, SERIAL (B)(4).; LIST 01L86-01, SERIAL (B)(4).