MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT ANTI-HCV

Catalog Number 06C37-32

Device Problem False Negative Result (1225)

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

Event Date 11/30/2019

Event Type  malfunction  

Manufacturer Narrative

Patient identifier multiple ids (b)(6).An evaluation is in process.A follow up report will be submitted when the evaluation is completed.

Event Description

The account generated false negative architect anti-hcv (0.17, 0.19, 0.19, 0.21, 0.19 s/co) results on a patient (b)(6) on (b)(6) 2019 and (b)(6) 2019 who tested nat positive and microplate method positive.No specific patient information was provided.No impact to patient management was reported.

Manufacturer Narrative

An investigation was performed for the customer issue and included a review of the complaint text, a search for similar complaints, a review of trending data, a review of product quality history, and a review of product labeling.Ticket searches determined that there is a normal complaint activity for the lot and the tracking and trending report review determined that there are no related trends.Return testing was not completed as returns were not available.A review of manufacturing documents did not identify any issues.A retained kit of architect anti-hcv reagent, lot number 06031be00 was calibrated on one instrument and the calibration met instrument specifications.Two sensitivity panels and the positive control were tested, and testing met specifications.The clinical sensitivity was evaluated, and sensitivity performance is not adversely affected.Labeling was reviewed and found to be adequate.Based on all available information and abbott diagnostics' complaint investigation a product deficiency was not 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: 9511684
• MDR Text Key: 219783930
• Report Number: 3002809144-2019-01081
• 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: 03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/12/2020
• Device Catalogue Number: 06C37-32
• Device Lot Number: 06031BE00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT LIST 03M74-02; ARCHITECT LIST 03M74-02,; SERIAL (B)(6) ; SERIAL (B)(6)