MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT ANTI-HCV

Catalog Number 06C37-37

Device Problem False Positive Result (1227)

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

Event Date 05/26/2020

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow up report will be submitted when the evaluation is complete.All available patient information is included.Additional patient details are not available.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 a false reactive architect anti-hcv assay result for a (b)(6) male patient.The customer provided that in 2016 the patient tested (b)(6) for hcv.On (b)(6) 2020, pre-op screening results provided initial result = (b)(6).Western blot testing was (b)(6).There was no impact to patient management reported.

Manufacturer Narrative

Evaluation results: the evaluation of the customers issue 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 field data review with the complaint lot number, 10583be00.Trending review determined no trend for the product.Device history record review did not identify any non-conformances or deviations with the lot and complaint issue.Field data review showed that the number of standard deviations to the cut-off and the median of the population tested with the complaint lot were within established limits.Further the repeat reactive rate observed for the complaint lot met the specificity performance.Based on all available information no product deficiency 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: 10186516
• MDR Text Key: 221584742
• Report Number: 3002809144-2020-00505
• 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: 07/15/2020

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: 07/31/2020
• Device Catalogue Number: 06C37-37
• Device Lot Number: 10583BE00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/01/2020
• Initial Date FDA Received: 06/23/2020
• Supplement Dates Manufacturer Received: 06/24/2020
• Supplement Dates FDA Received: 07/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR ANALYZER; ARCHITECT I2000SR ANALYZER; LN 03M74-01, SN (B)(6); LN 03M74-01, SN(B)(6)
• Patient Age: 54 YR