MAUDE Adverse Event Report: ABBOTT GERMANY ARCHITECT ANTI-HCV

Catalog Number 06C37-37

Device Problem Low Test Results (2458)

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

Event Date 07/20/2019

Event Type  malfunction  

Manufacturer Narrative

There was no additional patient information provided by the customer.An evaluation is in process.A final report will be submitted when the evaluation is complete.This report is being filed on an international product, list number 6c37 that has a similar product distributed in the us, list number 1l79.

Event Description

The customer reported (b)(6) architect anti-hcv on one female patient.The results provided were: on (b)(6) 2019, (b)(6), initial =(b)(6) / test of the original tube = (b)(6), elisa = (b)(6) / on (b)(6) 2019 same patient, different tube (b)(6)= (b)(6); sample sent to another site that tested abbott hcv antigen = (b)(6).There was no reported impact to patient management.

Manufacturer Narrative

A review of tickets determined that there are four other complaints for lot 01791be00 and no trends were identified for false nonreactive results.Return testing was not completed as returns were not available.Sensitivity testing was performed with a retained kit of lot 01791be00 and the results of this setup did not implicate that the performance of the lot is negatively impacted.Two sensitivity panels (core only panel and ns3 only panel) and additional replicates of the positive control were tested.The sensitivity panel and positive control values met specifications and the results were in the typical range and no false nonreactive results were obtained.In addition, the clinical sensitivity was evaluated by testing two commercially available seroconversion panels (zeptometrix hcv seroconversion panels hcv 9047 and hcv 9045).The seroconversion panel results were compared to architect anti-hcv test results provided by zeptometrix, lot 01791be00, 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 customer's observation.A review of labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the architect anti-hcv reagent, lot 01791be00.

• Brand Name: ARCHITECT ANTI-HCV
• Type of Device: ANTI-HCV
• Manufacturer (Section D): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 8888374
• MDR Text Key: 158975878
• Report Number: 3002809144-2019-00498
• Device Sequence Number: 1
• Product Code: MZO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/12/2019
• Device Catalogue Number: 06C37-37
• Device Lot Number: 01791BE00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR ANALYZER, LN 03M74-02,; ARCHITECT I2000SR ANALYZER, LN 03M74-02,; SERIAL # (B)(4); SERIAL # (B)(4)