MAUDE Adverse Event Report: ABBOTT GMBH ALINITY S ANTI-HCV II REAGENT KIT; HEPATITIS C VIRUS CORE (SYN PEPTIDE) AND NS3 HELICASE (E COLI, RECOMBINANT) AG

Catalog Number 04W56-56

Device Problem False Positive Result (1227)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/15/2023

Event Type  malfunction  

Manufacturer Narrative

Completed information for section a1 patient identifier: sids unknown (45 year old male), (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.

Event Description

The customer reported false reactive alinity s anti-hcv ii results for a 45-year-old male donor as compared to testing performed at two external labs.Donor history includes 12 donations since 2007 with all serologies (anti-hcv i) and nat results that were negative until (b)(6) 2022.The following results were provided: on (b)(6) 2023 (unknown sid) initial result = 10.71 s/co (reactive), inno-lia = positive (c1 bands and ns4 positive), nat ultrio-elite = negative confirmatory analysis = 9.0 s/co (reactive), inno-lia = (bands c1 and ns4 positive), nat ultrio-elite = negative the donor reports being healthy, questioning the results provided, and had two tests carried out at external laboratories, echevarne and megalab, in which the serology by chemiluminescence of total anti-hcv were negative.Additionally, the customer reported repeat reactive results for other donors that were inno-mia (immunoblot) and nat negative for the following sids: (b)(6).No impact to patient management was reported.

Event Description

The customer reported false reactive alinity s anti-hcv ii results for a 45-year-old male donor as compared to testing performed at two external labs.Donor history includes 12 donations since 2007 with all serologies (anti-hcv i) and nat results that were negative until (b)(6) 2022.The following results were provided: on (b)(6) 2023 initial result = 10.71 s/co (reactive), inno-lia = positive (c1 bands and ns4 positive), nat ultrio-elite = negative.Confirmatory analysis = 9.0 s/co (reactive), inno-lia = (bands c1 and ns4 positive), nat ultrio-elite = negative the donor reports being healthy, questioning the results provided, and had two tests carried out at external laboratories, echevarne and megalab, in which the serology by chemiluminescence of total anti-hcv were negative.Additionally, the customer reported repeat reactive results that were inno-mia (immunoblot) and nat negative for the following sids: (b)(6).No impact to patient management was reported.

Manufacturer Narrative

The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, device history record review, field data review and labeling review.Return testing was not completed as returns were not available.Data and information provided by the customer was reviewed and support the complaint issue.The search for similar complaints for lots 45373be00, 47286be00, 55140be00, and 51666be00 did not identify an increase in complaint activity for the issue.Ticket trending review of the complaint data for the lots 45373be00, 47286be00, 55140be00, and 51666be00 did not identify an increase in complaint activity for the complaint issue.Device history record review for the performance of lots 45373be00, 47286be00, 55140be00, and 51666be00 did not identify any non-conformances, potential non-conformances and deviations related to the complaint issue.The overall performance of the alinity s anti-hcv ii was reviewed using field data from customers worldwide.Overall reactive rates for lot numbers 45373be00, 47286be00, 55140be00, and 51666be00 for the customer¿s site, peer sites and across a whole blood and plasma screening monitoring group were collected and assessed.The performance for these lots is within product requirements.Labeling was reviewed and sufficiently addresses the customer¿s issue.The alinity s anti-hcv ii assay contains new antigen/reagent components as compared to abbott¿s previous and existing anti-hcv assays.This introduces new non-specific targets to a testing population.This introduction may impact the steady state level of specificity for a population.Because both first time and multiple time donors are naïve to this new method, false positive results can occur.This may lead to an initial rise in repeat reactive results until these donors have been excluded and assay steady state level of specificity for the population re-sets.¿false positive¿ determinations such as those evaluated may occur with a new anti-hcv ii assay due to either specific or non-specific reactions.The alinity s anti-hcv ii assay has been designed with improved seroconversion sensitivity compared with previous and existing abbott anti-hcv assays.With the introduction of a more sensitive assay, the scenario exists that detection of low-level antibody in a donor can occur.This could be an indication of treated or resolved hcv infection or the presence of hcv infection in an immunocompromised setting.The increased sensitivity of low-level antibody in a donor is a further protection of the blood supply.Based on the investigation the alinity s anti-hcv ii reagent lots 45373be00, 47286be00, 55140be00, and 51666be00 is performing as intended, no systemic issue or deficiency of the alinity s anti-hcv ii reagent was identified.

• Brand Name: ALINITY S ANTI-HCV II REAGENT KIT
• Type of Device: HEPATITIS C VIRUS CORE (SYN PEPTIDE) AND NS3 HELICASE (E COLI, RECOMBINANT) AG
• 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: 19003595
• MDR Text Key: 338982198
• Report Number: 3002809144-2024-00086
• Device Sequence Number: 1
• Product Code: QHM
• UDI-Device Identifier: 00380740177690
• UDI-Public: (01)00380740177690(17)240603(10)51666BE00
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/22/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 06/03/2024
• Device Catalogue Number: 04W56-56
• Device Lot Number: 51666BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2024
• Initial Date FDA Received: 03/29/2024
• Supplement Dates Manufacturer Received: 04/18/2024
• Supplement Dates FDA Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALIN S ANTI HCVII 2500T, 04W56-56, 45373BE00; ALIN S ANTI HCVII 2500T, 04W56-56, 45373BE00; ALIN S ANTI HCVII 2500T, 04W56-56, 47286BE00; ALIN S ANTI HCVII 2500T, 04W56-56, 47286BE00; ALIN S ANTI HCVII 2500T, 04W56-56, 55140BE00; ALIN S ANTI HCVII 2500T, 04W56-56, 55140BE00; ALNTY S SYSTEM, 06P16-01, (B)(6); ALNTY S SYSTEM, 06P16-01, (B)(6).