MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT ANTI-HCV

Model Number 1L79-25

Device Problem False Negative Result (1225)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/11/2019

Event Type  malfunction  

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 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.

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
• Type of Device: ANTI-HCV
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 9526965
• MDR Text Key: 190485703
• Report Number: 3002809144-2019-01094
• Device Sequence Number: 1
• Product Code: MZO
• UDI-Device Identifier: 00380740001414
• UDI-Public: 00380740001414
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 12/18/2019
• Initial Date FDA Received: 12/27/2019
• Supplement Dates Manufacturer Received: 03/16/2020
• Supplement Dates FDA Received: 03/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I1000SR PROCESSING MODULE; ARCHITECT I1000SR PROCESSING MODULE; LIST 01L86-01, SERIAL (B)(4).; LIST 01L86-01, SERIAL (B)(4).