MAUDE Adverse Event Report: ABBOTT GMBH ALINITY S ANTI-HCV REAGENT KIT; HEPATITIS C VIRUS ENCODED ANTIGENS (RECOMBINANT C100-3, HCR43)

Catalog Number	06P04-60
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed false positive alinity s anti-hcv results generated on two alinity s systems (b)(6) during a sensitivity/specificity study for multiple samples when compared to alinity s anti-hcv ii and confirmatory testing.The customer confirmed the new result values did not call into question any previously reported results.The following results were provided: (b)(6) anti-hcv (on (b)(6) results = 2.16 s/co, 1.96 s/co, 1.98 s/co, anti-hcv ii result = 0.03 s/co, confirmatory result = nonreactive.(b)(6) anti-hcv (on (b)(6) results = 1.93 s/co (on a different lot), 2.09 s/co, 1.70 s/co, anti-hcv ii result = 0.03 s/co, confirmatory result = nonreactive.(b)(6) anti-hcv results (on (b)(6) = 1.56 s/co, 1.60 s/co, 1.56 s/co, anti-hcv ii result = 0.04 s/co, confirmatory result = nonreactive.There was no impact to patient management.
Additional Manufacturer Narrative
Additional information for section a1 patient identifier: (b)(6).All other available patient information was included.Additional patient details are not provided.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
Additional information provided in section b5.
Event or Problem Description
The customer observed false positive alinity s anti-hcv results generated on two alinity s systems (b)(6) during a sensitivity/specificity study for multiple samples when compared to alinity s anti-hcv ii and confirmatory testing.The customer confirmed the new result values did not call into question any previously reported results.The following results were provided: (b)(6), anti-hcv (on (b)(6), results = 2.16 s/co, 1.96 s/co, 1.98 s/co, anti-hcv ii result = 0.03 s/co, confirmatory result = nonreactive.(b)(6), anti-hcv (on (b)(6), results = 1.93 s/co (on a different lot), 2.09 s/co, 1.70 s/co, anti-hcv ii result = 0.03 s/co, confirmatory result = nonreactive.(b)(6), anti-hcv results, (on (b)(6) = 1.56 s/co, 1.60 s/co, 1.56 s/co, anti-hcv ii result = 0.04 s/co, confirmatory result = nonreactive.There was no impact to patient management.Update: additional details were provided by the customer.Nat testing is done on site if the sample has repeat reactive results.If nat result is non-reactive, the sample is sent to an offsite testing facility (ortho).If nat result is consistent, offsite testing is not required.(b)(6) nat = nonreactive, ortho testing = nonreactive, (b)(6) nat = nonreactive, ortho testing = nonreactive, (b)(6) nat = nonreactive, ortho testing = nonreactive.
Event or Problem Description
The customer observed false positive alinity s anti-hcv results generated on two alinity s systems (b)(6) during a sensitivity/specificity study for multiple samples when compared to alinity s anti-hcv ii and confirmatory testing.The customer confirmed the new result values did not call into question any previously reported results.The following results were provided: (b)(6), anti-hcv (on (b)(6) results = 2.16 s/co, 1.96 s/co, 1.98 s/co, anti-hcv ii result = 0.03 s/co, confirmatory result = nonreactive.(b)(6) anti-hcv (on (b)(6) results = 1.93 s/co (on a different lot), 2.09 s/co, 1.70 s/co, anti-hcv ii result = 0.03 s/co, confirmatory result = nonreactive.(b)(6), anti-hcv results (on (b)(6) = 1.56 s/co, 1.60 s/co, 1.56 s/co, anti-hcv ii result = 0.04 s/co, confirmatory result = nonreactive.There was no impact to patient management.Update: additional details were provided by the customer.Nat testing is done on site if the sample has repeat reactive results.If nat result is non-reactive, the sample is sent to an offsite testing facility (ortho).If nat result is consistent, offsite testing is not required.(b)(6) nat = nonreactive, ortho testing = nonreactive, (b)(6) nat = nonreactive, ortho testing = nonreactive, (b)(6) nat = nonreactive, ortho testing = nonreactive.
Additional Manufacturer Narrative
The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, and field data review.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed.Detailed sample donor history including information about recent vaccinations, drug usage/medication, and information about the donors¿ general medical condition was unavailable.Considering the nonreactive alinity s anti-hcv ii, the nonreactive nat, and the nonreactive ortho results, it is difficult to definitively label these compiled sample results as true antibody positive.Additionally, improved assay performance over assays from earlier, or even the same generation can cause discrepant results between different serologic platforms and inconsistency on repeat testing.Ticket trending review did not identify any trends for the likely cause list or lot number(s).Device history record review did not identify any potential non-conformances, non-conformances, or deviations associated with the complaint lot(s).Overall reactive rates of the complaint lot(s) across (b)(6) (usa), applicable peer sites and across a whole blood and plasma screening monitoring group were collected and assessed.Across the whole blood and plasma monitoring group, (b)(6) (usa), and their peer sites the performance of the alinity s anti-hcv assay complaint lot(s) is within product requirements and comparable to the other lots analyzed in the comparison.At (b)(6) (usa), the specificity performance of the complaint lot(s) is comparable to peers.Labeling was reviewed which adequately addresses the current issue.Based on the investigation, the alinity s anti-hcv reagent is performing as intended, no systemic issue or deficiency of the alinity s anti-hcv reagent, lot 62165be00, was identified.

• Brand Name: ALINITY S ANTI-HCV REAGENT KIT
• Common Device Name: HEPATITIS C VIRUS ENCODED ANTIGENS (RECOMBINANT C100-3, HCR43)
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 20693922
• Report Number: 3002809144-2024-00321
• Device Sequence Number: 8584952
• Product Code: QHM
• UDI-Device Identifier: 00380740117191
• UDI-Public: (01)00380740117191(17)250214(10)62165BE00
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: BL 125677
• 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,Followup
• Report Date (Section B): 12/26/2024

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: 02/14/2025
• Device Catalogue Number: 06P04-60
• Device Lot Number: 62165BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2024
• Supplement Date Received by Manufacturer: 11/27/2024; 12/18/2024
• Initial Report FDA Received Date: 11/15/2024
• Supplement Report FDA Received Date: 12/16/2024; 12/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2024
• 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: ALNTY S SYSTEM, 06P16-01, (B)(6),; ALNTY S SYSTEM, 06P16-01, (B)(6),; ALNTY S SYSTEM, 06P16-01, (B)(6),; ALNTY S SYSTEM, 06P16-01, (B)(6),; ALNTY S SYSTEM, 06P16-01, (B)(6),; ALNTY S SYSTEM, 06P16-01, (B)(6).
• Patient Sex: Unknown