MAUDE Adverse Event Report: ABBOTT GMBH ALINITY I ANTI-HBC II REAGENT KIT; TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)

Catalog Number 07P87-22

Device Problem False Negative Result (1225)

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

Event Date 06/17/2022

Event Type  malfunction  

Event Description

The customer reported a false nonreactive alinity i anti-hbc result on a female patient in her 20¿s.Results provided: (b)(6) 2022 sid: (b)(6).Serial number (b)(4) hbc 1.25 / 1.32 s/co, after re-centrifuging = 1.38 s/co, this serial number: (b)(4) hbc 0.84 s/co, after re-centrifuging = 0.88 s/co, other results: hbsag, anti-hbs, and hbeab are all 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.This report is being filed on an international product, list number 7p87 that has a similar product distributed in the us, list number 7p84.

Manufacturer Narrative

The evaluation of complaint data for the product and likely cause alinity i anti-hbc ii reagent lot number 34555be00 identified normal complaint activity.No customer returns were available for evaluation.Manufacturing documentation for the likely cause lot did not identify any issues associated with the complaint issue.The performance of the likely cause lot was investigated by completing a review for non-conformances, potential non-conformances and deviations related to the likely cause lot.This review did not identify any non-conformances, potential non-conformances, or deviations.A retained reagent kit of the complaint lot was tested in a sensitivity setup.All specifications were met, and no false non-reactive results were obtained, indicating that the sensitivity performance is not negatively impacted.Additionally, the overall performance of alinity i anti-hbc ii reagents in the field was reviewed using data gathered via abbottlink from customers worldwide and suggested that the performance of the lot is acceptable.A review of the product labeling concluded that the issue is sufficiently addressed.No product systemic issue or deficiency was identified.

• Brand Name: ALINITY I ANTI-HBC II REAGENT KIT
• Type of Device: TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)
• 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: 14975502
• MDR Text Key: 304546243
• Report Number: 3002809144-2022-00236
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: N/A
• 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: 08/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/22/2022
• Device Catalogue Number: 07P87-22
• Device Lot Number: 34555BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY I PROCESSING MODU, 03R65-01, (B)(6).; ALNTY I PROCESSING MODU, 03R65-01, (B)(6).
• Patient Sex: Female