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	08/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed false repeat reactive alinity s anti-hcv results generated on the alinity s processing module for nine donors and/or stem cell patient samples which were nonreactive with the nat ultrio.The donor samples with nonreactive nat ultrio result were confirmed as positive by supplemental testing; however, the stem cell patient samples do not get sent out for supplemental testing.The nine samples were blinded as they were used for a validation study; therefore, it is unknown which of the nine samples were donor samples or stem cell patient samples.The customer provided one example.(b)(6) 2024 sid (b)(6) result = 4.67 s/co (reactive).Nat ultrio = nonreactive.No supplemental testing.There was no impact to donor/patient management reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
The complaint investigation for false reactive alinity s anti-hcv results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, device history record review, labeling review, and field data review.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue.A search for similar complaints did not identify an increase in complaint activity for lot 61101be00.Ticket trending review did not identify any trends for the issue for the product.Device history record review did not identify any nonconformances, potential nonconformances or deviations associate with lot 61101be00 and complaint issue.Labeling was reviewed and sufficiently addresses the complaint issue.A review of field data for alinity s anti-hcv was performed.Overall reactive rates for alinity s anti-hcv, list number 6p04-60 lot 61101be00 across md anderson blood center, 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, the customer and their peer sites, the performance of the lot 61101be00 is within product requirements.Based on the investigation, no systemic issue or deficiency was identified.The alinity s anti-hcv reagent, lot number 61101be00 is performing as expected.
Event or Problem Description
The customer observed false repeat reactive alinity s anti-hcv results generated on the alinity s processing module for nine donors and/or stem cell patient samples which were nonreactive with the nat ultrio.The donor samples with nonreactive nat ultrio result were confirmed as positive by supplemental testing; however, the stem cell patient samples do not get sent out for supplemental testing.The nine samples were blinded as they were used for a validation study; therefore, it is unknown which of the nine samples were donor samples or stem cell patient samples.The customer provided one example.(b)(6) 2024 sid (b)(6) result = 4.67 s/co (reactive); nat ultrio = nonreactive; no supplemental testing; there was no impact to donor/patient management reported.

• 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: 20479564
• Report Number: 3002809144-2024-00299
• Device Sequence Number: 15539503
• Product Code: QHM
• UDI-Device Identifier: 00380740117191
• UDI-Public: (01)00380740117191(17)250102(10)61101BE00
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2024

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: 01/02/2025
• Device Catalogue Number: 06P04-60
• Device Lot Number: 61101BE00
• 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: 09/23/2024
• Supplement Date Received by Manufacturer: 11/15/2024
• Initial Report FDA Received Date: 10/18/2024
• Supplement Report FDA Received Date: 11/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2024
• 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).
• Patient Sex: Unknown