MAUDE Adverse Event Report: ABBOTT LABORATORIES ABBOTT PRISM HCV ASSAY KIT; HEPATITIS C VIRUS ENCODED ANTIGENS (RECOMBINANT C100-3, HCR43, NS5)

Catalog Number	06D18-68
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2021
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.There was no further information provided by the customer for donors.
Event or Problem Description
The customer observed (b)(6) abbott prism anti- hcv assay on one donor specimens when comparing to alinity s processing module.The results provided were: on (b)(6) 2021 sid (b)(6) =(b)(6) / repeated on alinity s=(b)(6) there was no reported impact to patient management.
Additional Manufacturer Narrative
The complaint evaluation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, of prism hcv reagent lot number 24026m700.Trending review determined no adverse trend for the issue for the product.Return testing was not completed as returns were not available.In-house sensitivity testing was performed with five different hcv sensitivity panels and all specifications met specification.Device history record review did not identify any non-conformances or deviations with the complaint lot and complaint issue.A technical evaluation of differences between alinity s anti-hcv and abbott prism hcv was performed.While both the alinity s anti-hcv assay (ln 06p04) and prism hcv assay (ln 6d18) utilize chemiluminescence to generate a signal (amount of emitted light), which is proportional to the amount of analyte detected, the assays differ in their principle and composition.With regards to specificity, the alinity s anti-hcv assay design validation study with prism hcv as comparator assay yielded for the same donor population tested on alinity s and prism an overall final agreement for total donors between these two assays of 99.88%, with a 95% ci of 99.82% to 99.93%.Due to differences in platform, methodology and assay design, different results between the assays and platforms cannot be excluded.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.There was no issue with reagent performance identified.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the prism hcv reagent lot number 24026m700.

• Brand Name: ABBOTT PRISM HCV ASSAY KIT
• Common Device Name: HEPATITIS C VIRUS ENCODED ANTIGENS (RECOMBINANT C100-3, HCR43, NS5)
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064
• Manufacturer (Section G): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064
• Manufacturer Contact: christian lee ; 100 abbott park road; dept. 09b9, lc cp01-3; abbott park, IL 60064-3537 ; 2246682940
• MDR Report Key: 12729274
• Report Number: 1415939-2021-00047
• Device Sequence Number: 16510750
• Product Code: QHM
• UDI-Device Identifier: 00380740062996
• UDI-Public: 00380740062996
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2021

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: 02/10/2022
• Device Catalogue Number: 06D18-68
• Device Lot Number: 24026M700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/12/2021
• Supplement Date Received by Manufacturer: 11/16/2021
• Initial Report FDA Received Date: 11/01/2021
• Supplement Report FDA Received Date: 11/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PRISM 6 CHANNEL-CE, 06A36-04, 1361.; PRISM 6 CHANNEL-CE, 06A36-04, 1361.; PRISM 6 CHANNEL-CE, 06A36-04, 1361
• Patient Sex: Unknown