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 02/01/2023

Event Type  malfunction  

Event Description

The customer observed a false non-reactive alinity i anti-hbc ii result generated on an alinity i processing module for a patient.The following data was provided: anti-hbc initial result = negative, hbsag = positive, which was weakly positive with the confirmatory test.The physician questioned the non-reactive anti-hbc result.The sample was repeated and was positive.No impact to patient management was reported.

Manufacturer Narrative

An evaluation is in process.A final report will be submitted when the evaluation is complete.Reporter name and address: phone 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 7p87 that has a similar product distributed in the us, list number 7p84.

Manufacturer Narrative

The complaint investigation for false non-reactive alinity i anti-hbc ii included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, and in house sensitivity testing.Return testing was not completed as returns were not available.A review of tracking and trending did not identify any trends for the complaint issue.Device history record review did not identify any non-conformances or deviations with lot 46038be00 and the complaint issue.In-house testing of a retained reagent kit of the complaint lot was performed, showing that the lot generates the expected results.In addition, the clinical sensitivity of the lot was evaluated by testing two commercially available seroconversion panels (biomex seroconversion panel scp-hbv-001 and scp-hbv-004).The seroconversion panel results were compared to architect anti-hbc test results provided by biomex.The lot detected the same bleeds as reactive for the seroconversion panels.Based on these data it was shown that the sensitivity performance of the complaint lot is not impacted.Labeling was reviewed and found to adequately address the issue under review.Based on the investigation, no systemic issue or deficiency of the alinity i anti-hbc ii reagent for lot 46038be00 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: 16325555
• MDR Text Key: 309086670
• Report Number: 3002809144-2023-00077
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 03/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/17/2023
• Device Catalogue Number: 07P87-22
• Device Lot Number: 46038BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2022
• 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, AI03857.; ALNTY I PROCESSING MODU, 03R65-01, AI03857.