MAUDE Adverse Event Report: ABBOTT LABORATORIES PRISM HCV; ANTI-HCV

Catalog Number 06D18-68

Device Problem False Positive Result (1227)

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

Event Date 06/24/2019

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Patient identifier: multiple = (b)(6).Patient information: no further donor information was provided.

Event Description

The customer reported false repeat reactive abbott prism hcv results for two donor samples.The customer indicated the donors' previous and subsequent donation were non-reactive.Donor 1: (b)(6) 2019 id (b)(6) non-reactive, (b)(6) 2019 id (b)(6) repeat reactive, (b)(6) 2019 id (b)(6) non-reactive.Donor 2: (b)(6) 2019 id (b)(6)non-reactive, (b)(6) 2019 id (b)(6) repeat reactive, (b)(6) 2019 id (b)(6) non-reactive.No impact to donor management was reported.

Manufacturer Narrative

Investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of the manufacturing documentation, review of field data, and a review of labeling.Return testing was not completed as returns were not available.Review of complaint trending reports did not identify any trends for the abbott prism hcv assay.Review of complaint activity determined that there is normal complaint activity for reagent lot 03109m700.Field data was reviewed to evaluate initial reactive rate, repeat reactive rate and specificity of reagent lot 03109m700.The initial reactive rate was 0.10% and repeat reactive rate was 0.08%, which are within package insert specifications.Additionally, assuming a zero prevalence of hcv for the tested samples, the specificity of lot 03109m700 would be within package insert specifications.Manufacturing documentation for the reagent lot did not identify any issues associated with the complaint issue.Additionally, a review of labeling concluded that the issue was sufficiently addressed.Based on the available information, no systemic issue or deficiency of the abbott prism hcv assay was identified.

Manufacturer Narrative

An error was identified on february 13, 2020.The incorrect product code of mzo (section d.2b) was used in the previous submissions.The correct code is qhm, this report is being submitted to correct the product code.No further changes or corrections to the product information or evaluation are needed.

• Brand Name: PRISM HCV
• Type of Device: ANTI-HCV
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• MDR Report Key: 9475721
• MDR Text Key: 219765240
• Report Number: 1415939-2019-00231
• Device Sequence Number: 1
• Product Code: QHM
• UDI-Device Identifier: 00380740062996
• UDI-Public: 00380740062996
• 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,Followup
• Report Date: 03/09/2020

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: 02/17/2020
• Device Catalogue Number: 06D18-68
• Device Lot Number: 03109M700
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/03/2019
• Initial Date FDA Received: 12/16/2019
• Supplement Dates Manufacturer Received: 12/20/2019; 02/13/2020
• Supplement Dates FDA Received: 01/09/2020; 03/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: (B)(6) AND 1422.; 01399-96 AND 1422; ABBOTT PRISMNEXT 6 CHANNEL ANALYZER,; ABBOTT PRISMNEXT 6 CHANNEL ANALYZER,; ABBOTT PRISMNEXT 6 CHANNEL ANALYZER,; AND 1422; LIST 06A36-11, SERIALS (B)(6) ,; LIST 06A36-11, SERIALS (B)(6) ,; LIST 06A36-11, SERIALS (B)(6) , (B)(6)