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

Catalog Number 06P04-55

Device Problem False Negative Result (1225)

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

Event Date 10/31/2022

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed false nonreactive alinity s anti-hcv results when compared to other methods.The following data was provided: case 1: 41 year old male, date of donation: (b)(6) 2021, sid (b)(6), anti-hcv nonreactive (0.09), anti-hcv ii reactive (3.03), roche hcv 0.04 (negative), nat nonreactive, previous anti-hcv results nonreactive (0.1 / 0.08 / 0.08 / 0.1 / 0.14).Case 5: 42 year old female, date of donation: (b)(6) 2022, sid (b)(6).Anti-hcv nonreactive (0.07), anti-hcv ii reactive (1.97), roche hcv 0.043 (negative), western blot indeterminate, previous anti-hcv results nonreactive (0.11).Case 6: 50 year old male, date of donation: (b)(6) 2020, sid (b)(6), anti-hcv nonreactive (0.66), alinity s anti-hcv ii reactive (85.55), roche reactive (15.24), nat nonreactive, western blot indeterminate, previous anti-hcv results nonreactive (0.72 / 0.76).Case 7: 35 year old male, date of donation: (b)(6) 2021, sid (b)(6), anti-hcv nonreactive (0.1), alinity s anti-hcv ii reactive (29.39), nat nonreactive, roche hcv reactive (9.05), western blot negative.Case 8: 44 year old male, date of donation: (b)(6) 2021, sid (b)(6), anti-hcv nonreactive (0.14), alinity s anti-hcv ii reactive (1.2), nat nonreactive, roche hcv nonreactive (0.046), western blot indeterminate.Case 14: 32 year old male, date of donation: (b)(6) 2022, sid (b)(6), anti-hcv nonreactive (0.41), alinity s anti-hcv ii reactive (4.44), nat nonreactive, roche hcv negative (1.55).Case 15: 38 year old male, date of donation: (b)(6) 2021, sid (b)(6), anti-hcv nonreactive (0.18), alinity s anti-hcv ii reactive (3.47), nat nonreactive, roche hcv negative (1.21).No impact to patient management was reported.

Event Description

The customer observed false nonreactive alinity s anti-hcv results when compared to other methods.The customer performed a look-back study and additional clarifying information was received on 09feb2023.The customer is questioning potentially false negative alinity s anti-hcv results for these 5 donor patients.Sid (b)(6) (current donation), 50 year old male, anti-hcv nonreactive (0.66 / 0.72 / 0.76), alinity s anti-hcv ii reactive (80.85 / 85.55 / 77.12), roche reactive (13.09 / 15.24 / 13.9), nat nonreactive, western blot indeterminate.Sid (b)(6) (current donation), 35 year old male anti-hcv nonreactive (0.1), alinity s anti-hcv ii reactive (27.38 / 29.39), roche hcv reactive (8.8 / 9.05), nat nonreactive, western blot negative.Sid (b)(6) (current donation), 33 year old male anti-hcv nonreactive alinity s hcv ii reactive (12.93) roche hcv reactive (9.19) nat nonreactive western blot indeterminate.Sid (b)(6) (current donation), 32 year old male anti-hcv nonreactive (0.41), alinity s anti-hcv ii reactive (3.98 / 4.44), roche hcv reactive (1.51 / 1.55) nat nonreactive, western blot indeterminate.Sid (b)(6) (current donation), 38 year old male anti-hcv nonreactive (0.18), alinity s anti-hcv ii reactive (3.14 / 3.47), roche hcv reactive (1.23 / 1.21) nat nonreactive, western blot negative.No impact to patient management was reported.

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Corrected information found in section b5.

Manufacturer Narrative

Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.Evaluation of complaint data for the product did not identify an increase in complaint activity for the complaint issue.Device history record review was performed on lot 27291be00, which did not show any potential non-conformances, deviations, or non-conformances.Trending review did not identify any trends.A review of labeling concluded that the issue is sufficiently addressed.In this complaint ticket, negative abbott anti-hcv results had been obtained on previous samples from 4 of 5 repeat donors (no prior serology results were available for 1 donor).The donors¿ current donations (sids (b)(6)) were positive on abbott anti-hcv ii and roche anti-hcv.Screening for hcv nat was negative on the current and all previous documented donations.Current samples were sent to abbott for repeat anti-hcv ii testing on alinity s.This repeat testing was performed on a different assay lot* as the likely cause lot was expired.See results summary below: sample id / date of donation / abbott anti-hcv / abbott anti-hcv ii / western blot / nat result / repeat alinity s anti-hcv ii s/co* (b)(6) / (b)(6) 2022 / not performed / reactive / reactive / indeterminate / negative / insufficient sample volume error; no test (b)(6)/ (b)(6) 2022 / not performed / reactive / reactive / negative / negative / insufficient sample volume error; no test (b)(6) / (b)(6) 2022 / not performed / reactive / reactive / indeterminate / negative / reactive** (b)(6) / (b)(6) 2022 / not performed / reactive / reactive / indeterminate / negative / reactive** (b)(6) / (b)(6) 2022 / not performed / reactive / reactive / indeterminate / negative / reactive** *lot number 47283be00 **duplicate retests could not be performed due to insufficient sample volume the alinity s anti-hcvii assay was designed with improved seroconversion sensitivity compared with the alinity s and architect anti-hcv assays.Detection of early acute infection and resolved/treated hcv infections in donors with lower antibody titers was improved with the new assay.The enhanced sensitivity of this assay enables earlier detection with comparable specificity.The scenario exists that detection of low-level antibody in a donor could occur when converting to a more sensitive screening assay.The scenario for this type of donor is an indication of treated or resolved hcv infection or the presence of hcv infection in an immunocompromised setting.The increased sensitivity to low-level antibody in a donor represents further protection of the blood supply.In clinical studies comparing both assays on the same donor population the alinity s anti-hcv ii assay showed comparable specificity to the older anti-hcv assays.Therefore, the rate of false positive samples is expected to be comparable when used in the same donor population, although the nonspecific samples for each assay may not be comprised of the same subpopulation.Complete alignment of results for identical samples may not occur between methods when performing a method comparison.Differences between sample results using the current method and the new method may be due to a difference in sensitivity and/or specificity.A new screening assay contains new antigens / antibody components and/or reagents that introduce new nonspecific targets to the customer¿s testing population; this may result in repeat reactive results that are subsequently identified as ¿false positive.¿ this rate is typically higher in first-time donors as compared to repeat donors.In such cases the nonspecific phenomenon for repeat donors has already occurred when the assay is in routine use and has reached steady state level of specificity for the site¿s population.The introduction of a new assay may temporarily disrupt this steady state.A detailed donor history including information about recent vaccinations, drug usage/medication, and information about the general medical condition is unavailable.Considering the results obtained in total, it is difficult to definitively label these compiled sample results as true or false antibody-positive.Discordant serology and nat results are an indication to defer a donor, and algorithms exist whereby deferred donors may subsequently present for reentry.In this complaint all 5 of the donors fall into a donor group who may in another country be deferred for reactive serology results and nonreactive hcv nat, and they would be eligible for reentry screening at a later date.This group includes donors who have history of indeterminate or negative immunoblot (riba) results.It should be noted that the same deferral period and opportunity for reentry would exist for a negative serology result with reactive nat result.In both scenarios, these donors would submit samples for follow-up testing after a defined minimum period from the implicated donation.The hcv immune response pathophysiology is well-documented, as are various hcv markers and the pattern of detection used to diagnose hcv.In the absence of complete, detailed donor history and hcv serologic marker test results (serology results from 1 of the prior donations are unavailable for review), it should be noted that presence of antibodies does not provide information about whether or not a self-limiting or chronic hcv infection occurred.Resolving disease cannot be differentiated from progressive disease by the interval between exposure and first appearance of antibody.In resolved acute cases the amount of hcv rna can be undetectable.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.Based on this investigation, no systemic issue or deficiency of the alinity s anti-hcv assay was identified.

Event Description

The customer observed false nonreactive alinity s anti-hcv results when compared to other methods.The customer performed a look-back study and additional clarifying information was received on (b)(6) 2023.The customer is questioning potentially false negative alinity s anti-hcv results for these 5 donor patients.Sid (b)(6) (current donation), 50 year old male, anti-hcv nonreactive (0.66 / 0.72 / 0.76), alinity s anti-hcv ii reactive (80.85 / 85.55 / 77.12), roche reactive (13.09 / 15.24 / 13.9), nat nonreactive, western blot indeterminate sid (b)(6) (current donation), 35 year old male anti-hcv nonreactive (0.1), alinity s anti-hcv ii reactive (27.38 / 29.39), roche hcv reactive (8.8 / 9.05), nat nonreactive, western blot negative sid (b)(6) (current donation), 33 year old male anti-hcv nonreactive alinity s hcv ii reactive (12.93) roche hcv reactive (9.19) nat nonreactive western blot indeterminate sid (b)(6) (current donation), 32 year old male anti-hcv nonreactive (0.41), alinity s anti-hcv ii reactive (3.98 / 4.44), roche hcv reactive (1.51 / 1.55) nat nonreactive, western blot indeterminate sid (b)(6) (current donation), 38 year old male anti-hcv nonreactive (0.18), alinity s anti-hcv ii reactive (3.14 / 3.47), roche hcv reactive (1.23 / 1.21) nat nonreactive, western blot negative.No impact to patient management was reported.

• Brand Name: ALINITY S ANTI-HCV REAGENT KIT
• Type of Device: 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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 16283874
• MDR Text Key: 309268812
• Report Number: 3002809144-2023-00068
• Device Sequence Number: 1
• Product Code: QHM
• Combination Product (y/n): N
• Reporter Country Code: TC
• 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,Followup
• Report Date: 05/18/2023

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: 03/29/2022
• Device Catalogue Number: 06P04-55
• Device Lot Number: 27291BE00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2023
• Initial Date FDA Received: 02/02/2023
• Supplement Dates Manufacturer Received: 02/09/2023; 05/03/2023
• Supplement Dates FDA Received: 03/03/2023; 05/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY S SYSTEM, 06P16-01, (B)(6) ; ALNTY S SYSTEM, 06P16-01, (B)(6) ; ALNTY S SYSTEM, 06P16-01, (B)(6)