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	10/08/2021
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.
Event or Problem Description
The customer observed a (b)(6) abbott prism hcv result for a donor specimen when comparing to the alinity s analyzer.The following results provided: on (b)(6) 2021 sample id (b)(6): prism (01293) hcv result = (b)(6), nat = (b)(6), alinity s anti - hcv results = (b)(6) there was no impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation for falsely nonreactive abbott prism hcv results included a search for similar complaints, and the review of complaint text, trending data, labeling, in-house testing, and device history records.Return testing was not performed as returns were not available.The complaint activity for the lot 24026m700 identified normal complaint activity.The trending review determined no trends were identified for the product for the issue.Clinical sensitivity testing was done using an in-house retained kit of the complaint lot 24026m700.Replicates of 5 different hcv sensitivity panels were tested.The sensitivity panels met specifications.Device history record review determined no non-conformances or deviations were identified.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.Labeling was reviewed and adequately addresses issue under review.Based on the investigation, no systemic issue or product deficiency for abbott prism hcv reagent lot 24026m700 was identified.

• 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: 12707937
• Report Number: 1415939-2021-00046
• Device Sequence Number: 4641177
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2021

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: 10/13/2021
• Supplement Date Received by Manufacturer: 11/16/2021
• Initial Report FDA Received Date: 10/27/2021
• Supplement Report FDA Received Date: 11/19/2021
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PRSM NEXT RFRB IN, 06A36-11, 01293-96; PRSM NEXT RFRB IN, 06A36-11, 01293-96
• Patient Sex: Unknown