MAUDE Adverse Event Report: ABBOTT GMBH ALINITY S ANTI-HBC REAGENT KIT; HEPATITIS B VIRUS CORE ANTIGEN (E COLI, RECOMBINANT)

Catalog Number 06P06-55

Device Problem False Negative Result (1225)

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

Event Date 09/09/2022

Event Type  malfunction  

Event Description

The customer observed false nonreactive alinity s anti-hbc results for one donor during a lookback, who was found to be hepatitis b core positive in (b)(6) 2023.The following data was provided (<1.00 s/co is nonreactive, >/=1.00 s/co is reactive): sample id (b)(6) result, on (b)(6) 2022 with lot number 37325be00, was 0.91 s/co.The sample was sent for confirmation testing on (b)(6) 2023 and was positive with a diasorin assay, the anti-hbs result was 435.73 miu/ml, the nat testing was negative, and the hbv dna not detected.The sample was retested on (b)(6) 2023, with lot number 49212be00, and the result was 0.93 s/co.There was no impact to patient management reported.

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Section a1 - patient identifier complete entry = (b)(6).All available patient information was included.Additional patient details are not available.This report is being filed on an international product, list number 06p06-55, that has a similar product distributed in the us, list number 06p06-60.

Manufacturer Narrative

The complaint investigation for false nonreactive alinity s anti-hbc results included a search for similar complaints, review of complaint text, trending data, labeling, device history records, and in-house testing.Trending review determined no related trend for the issue for the product.Sensitivity testing was performed using an in-house retained kit of lot 49212be00 stored at the recommended storage condition.All specifications were met, and no false non-reactive results were obtained, indicating that the lot is performing acceptably.The clinical sensitivity of the lot was evaluated by testing two commercially available seroconversion panels (zeptometrix hbv6281 and biomex scp-hbv-004).The seroconversion panel results were compared to historical data of alinity s anti-hbc and reagent lot 49212be00 detected the same bleeds as reactive for the seroconversion panels.Based on these data, it was shown that the sensitivity performance of the complaint lots is not negatively impacted.Note: alinity s anti-hbc reagent lot number 37325be00 expired on 2023-04-19, therefore, no sensitivity testing could be performed for this lot.Device history record review did not identify any non-conformances or deviations with the likely cause lot and complaint issue.Manufacturing documentation for the likely cause lot was reviewed and did not identify any issues.Labeling was reviewed and sufficiently addresses the customer's issue.Per abbott technical, any samples not identified as reactive by either method that are identified as reactive by the other method and within the zone of equivalence are considered equivalent.The zone of equivalence is the assay cutoff +/- (2*precision %cv).Accordingly, samples with discordant results and values within the range of 0.8 and 1.2 s/co are considered equivalent.Anti-hbc positivity can be seen in the setting of prior exposure or ongoing infection.The anti-hbc positive results provided in this complaint are within the assay bias/margin of equivalence to the prior negative anti-hbc results obtained from this donor.The overall results are not indicative of a false negative result.Potential harm to recipients was ruled out by the reporting site.Based on the information provided and abbott diagnostics¿ complaint investigation, alinity s anti-hbc lot numbers 37325be00 and 49212be00 are performing as intended, no systemic issue or deficiency of the reagent was identified.

Event Description

The customer observed false nonreactive alinity s anti-hbc results for one donor during a lookback, who was found to be hepatitis b core positive in (b)(6) 2023.The following data was provided (<1.00 s/co is nonreactive, >/=1.00 s/co is reactive): sample id (b)(6) result, on (b)(6) 2022 with lot number 37325be00, was 0.91 s/co.The sample was sent for confirmation testing on (b)(6) 2023 and was positive with a diasorin assay, the anti-hbs result was 435.73 miu/ml, the nat testing was negative, and the hbv dna not detected.The sample was retested on (b)(6) 2023, with lot number 49212be00, and the result was 0.93 s/co.There was no impact to patient management reported.

• Brand Name: ALINITY S ANTI-HBC REAGENT KIT
• Type of Device: HEPATITIS B VIRUS CORE ANTIGEN (E COLI, RECOMBINANT)
• 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: 17686212
• MDR Text Key: 322707239
• Report Number: 3002809144-2023-00381
• Device Sequence Number: 1
• Product Code: QHM
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 10/04/2023

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: 04/05/2024
• Device Catalogue Number: 06P06-55
• Device Lot Number: 49212BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/16/2023
• Initial Date FDA Received: 09/05/2023
• Supplement Dates Manufacturer Received: 09/20/2023
• Supplement Dates FDA Received: 10/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY S ANTI-HBC 2500T, 06P06-55, (B)(6) ; ALNTY S ANTI-HBC 2500T, 06P06-55, (B)(6) ; ALNTY S SYSTEM, 06P16-01, (B)(6) ; ALNTY S SYSTEM, 06P16-01, (B)(6)