MAUDE Adverse Event Report: ABBOTT IRELAND ALINITY I HBSAG QUALITATIVE II REAGENT KIT; TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)

Catalog Number 08P10-22

Device Problem False Positive Result (1227)

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

Event Date 08/20/2022

Event Type  malfunction  

Event Description

The customer stated that repeat reactive alinity i hbsag qualitative ii results were generated for a patient (b)(6).On (b)(6)2022 initial result 5.12 s/co (reactive); alinity i hbsag qualitative ii confirmatory 85% (confirmed positive).On (b)(6)2022 repeat result 1.4 s/co (reactive).The reactive results were not consistent with the patient's clinical history.A new sample (b)(6) was drawn from the same patient on (b)(6) and the result was nonreactive at 0.32 s/co.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.All available patient information was included.Additional patient details are not available.

Manufacturer Narrative

Trending review determined no adverse trend for the issue for the product.Historical complaint review determined there is normal complaint activity for the lot number.Device history record review did not show any potential non-conformances, or deviations.Labeling was reviewed and found to adequately address the issue under review.Historical performance in the field of reagent lots using worldwide data through abbottlink was evaluated.The patient median result for the lot is comparable with all other lots in the field and within established baselines, confirming no systemic issue for the product lot.Based on the investigation, no deficiency for lot number 39377fn00 was identified.

• Brand Name: ALINITY I HBSAG QUALITATIVE II REAGENT KIT
• Type of Device: TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)
• Manufacturer (Section D): ABBOTT IRELAND; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer (Section G): ABBOTT IRELAND; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 15374053
• MDR Text Key: 300215132
• Report Number: 3008344661-2022-00103
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P110029
• 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: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/12/2023
• Device Catalogue Number: 08P10-22
• Device Lot Number: 39377FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY I HBS AG QUAL CON, 08P11-22, 39377FN00; ALNTY I PROCESSING MODU, 03R65-01, (B)(6); ALNTY I PROCESSING MODU, 03R65-01,(B)(6)