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

Catalog Number	06D18-68
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/24/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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.
Additional 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
• Common Device Name: ANTI-HCV
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• MDR Report Key: 9475721
• Report Number: 1415939-2019-00231
• Device Sequence Number: 14175608
• Product Code: QHM
• UDI-Device Identifier: 00380740062996
• UDI-Public: 00380740062996
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 12/03/2019
• Supplement Date Received by Manufacturer: 12/20/2019; 02/13/2020
• Initial Report FDA Received Date: 12/16/2019
• Supplement Report FDA Received Date: 01/09/2020; 03/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: (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)