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 Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Was this device serviced by a third party? no.(b)(6).All available patient information included.No additional information was provided.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete this mdr is being submitted for the prism (b)(6) reagent, list 06d18-68.
Event or Problem Description
The customer reported (b)(6) prism chagas, prism (b)(6), and prism htlv results were generated.The customer stated that the samples were archived then run on the alinity s for validation testing as ¿known¿ (b)(6) but they generated (b)(6) results.The following results were provided: sid (b)(6)- (b)(6) 2021 prism chagas repeat prism chagas repeat reactive (1.40, 1.47, 1.39 s/co) (lot 15094m700); (b)(6) 2021- alinity s non-reactive (0.14 s/co); esa indeterminate sid (b)(6)- (b)(6) 2021 prism chagas repeat reactive (1.78, 2.61, 2.55 s/co) (lot 15094m700); (b)(6) 2021- alinity s non-reactive (0.02 s/co); esa negative sid (b)(6) - (b)(6) 2021 prism htlv repeat reactive (1.94, 1.88, 1.76 s/co);(b)(6) 2021- alinity s non-reactive (0.14 s/co); mp htlv blot negative sid (b)(6)- (b)(6) 2021 prism htlv repeat reactive (1.93, 2.01, and 1.99 s/co); (b)(6) 2021- alinity s non-reactive (0.13 s/co); mp htlv blot indeterminate sid (b)(6)- (b)(6) 2021 prism htlv repeat reactive (1.25, 1.47, 1.39 s/co); (b)(6) 2021- alinity s non-reactive (0.16 s/co); mp htlv blot invalid sid (b)(6)- (b)(6) 2021 prism (b)(6) repeat (b)(6); (b)(6) 2021- alinity s (b)(6); ortho (b)(6), roche nat (b)(6) there was no reported impact to patient management.
Event or Problem Description
The customer reported false repeat reactive prism chagas, prism hcv, and prism htlv results were generated.The customer stated that the samples were archived then run on the alinity s for validation testing as ¿known¿ positives but they generated non-reactive results.The following results were provided: sid (b)(4)- (b)(6) 2021 prism chagas repeat reactive (1.40, 1.47, 1.39 s/co) (lot 15094m700); (b)(6) 2021- alinity s non-reactive (0.54 s/co); esa indeterminate.Sid (b)(4)- (b)(6) 2021 prism chagas repeat reactive (1.78, 2.61, 2.55 s/co) (lot 15094m700); (b)(6) 2021- alinity s non-reactive (0.02 s/co); esa negative.Sid (b)(4)- (b)(6) 2021 prism htlv repeat reactive (1.94, 1.88, 1.76 s/co); (b)(6) 2021- alinity s non-reactive (0.14 s/co); mp htlv blot negative.Sid (b)(4)- (b)(6) 2021 prism htlv repeat reactive (1.93, 2.01, and 1.99 s/co); (b)(6) 2021- alinity s non-reactive (0.13 s/co); mp htlv blot indeterminate.Sid (b)(4)- (b)(6) 2021 prism htlv repeat reactive (1.25, 1.47, 1.39 s/co); (b)(6) 2021- alinity s non-reactive (0.16 s/co); mp htlv blot invalid.Sid (b)(4)- (b)(6) 2021 prism hcv repeat reactive (1.26, 1.20, 1.24 s/co); (b)(6) 2021- alinity s non-reactive (0.06 s/co); ortho hcv nonreactive, roche nat negative there was no reported impact to patient management.
Additional Manufacturer Narrative
A review of complaints abbott prism chagas, list number (ln) (b)(4), lot 15094m700, abbott prism hcv, (b)(4), lot 20049m700 , and abbott prism htlv-i/htlv-ii, (b)(4), lot 22075m700 identified normal complaint activity for all lots involved.A review of ticket trending was performed an no trend was identified for the customer complaint for the abbott prism chagas, list number (ln) (b)(4)), abbott prism hcv, (b)(4), and the abbott prism htlv-i/htlv-ii, (b)(4) reagents.A review of customer data was performed including the repeat reactive rates (rrr) for abbott prism chagas lot 15094m700, abbott prism hcv lot 20049m700 and abbott prism htlv-i/htlv-ii lot 22075m700.It was found that the customer rrr were within the package insert ranges for data for abbott prism chagas lot 15094m700 and abbott prism hcv lot 20049m700.For abbott prism htlv-i/htlv-ii lot 22075m700, the (b)(4) rrr exceeded the overall total donor upper 95% confidence limit but was still within the range of expected performance for any single abbott prism htlv-i/htlv-ii lot ((b)(4)) as shown in the package insert.Manufacturing documentation was reviewed and no issues were identified.Additionally, labeling was reviewed and sufficiently addresses the customer issue.Based on the results of this investigation, there is no systemic issue or deficiency was identified for the prism chagas lot 15094m700, prism hcv lot 20049m700 and prism htlv-i/htlv-ii lot 22075m700.This follow up is submitted to populate fields d8 and/or h6 with data that had previously been provided in field h10.There is no change to the content of the data.

• 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
• MDR Report Key: 11656353
• Report Number: 1415939-2021-00014
• Device Sequence Number: 11818383
• Product Code: QHM
• UDI-Device Identifier: 00380740062996
• UDI-Public: 00380740062996
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 06/09/2021

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: 06/24/2021
• Device Catalogue Number: 06D18-68
• Device Lot Number: 20049M700
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/26/2021
• Supplement Date Received by Manufacturer: 06/07/2021
• Initial Report FDA Received Date: 04/13/2021
• Supplement Report FDA Received Date: 06/09/2021
• 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: PRISM 6 CHANNEL-CE, 06A36-04, 1174; PRISM 6 CHANNEL-CE, 06A36-04, 1174; PRISM CHAGAS US A, 07K35-68, 15094M700; PRISM CHAGAS US A, 07K35-68, 15094M700; PRSM HTLV RGT KIT, 06E50-68, 22075M700; PRSM HTLV RGT KIT, 06E50-68, 22075M700