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

Catalog Number 08P08-77

Device Problem False Positive Result (1227)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/09/2021

Event Type  malfunction  

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.(b)(6).This report is being filed on an international product, list number 08p08, that has a similar product distributed in the us, list number 04p53.

Event Description

The customer observed a (b)(6) alinity i hbsag result for one patient.The following data was provided ((b)(6)): sample id (b)(6) initial result, on (b)(6)2021, was 1.92, repeat, on (b)(6) 2021, was 0.00 iu/ml.The patients samples before (b)(6) 2021 were (b)(6).Additional laboratory testing from (b)(6) 2021 was provided (no units of measure were provided): (b)(6) was (b)(6), (b)(6) was (b)(6), (b)(6) was (b)(6), (b)(6) was (b)(6).The patient had a pre-scheduled gastroscopy procedure done on (b)(6) 2021 with equipment used for patients with (b)(6) testing because of the (b)(6) hbsag result.There was no harm to the patient and the patient did not receive any treatment based on the (b)(6) alinity i hbsag result.

Manufacturer Narrative

Health effect impact code: f26, component code: g01003.D8.Was this device serviced by a third party? no.The complaint investigation for a false initial reactive alinity i hbsag result included a search for similar complaints, review of complaint text, trending data, labeling, and device history records.Return testing was not completed as returns were not available.Review of trending reports for the alinity i hbsag reagent did not identify any related trends.Historical performance in the field of reagent lots using worldwide data through abbottlink was evaluated.The patient median result for the lot are comparable with all other lots in the field and confirms no systemic issue for the product lot.Manufacturing documentation for the likely cause lot was reviewed and did not identify any issues.Labeling was reviewed and found to adequately address the issue under review.In this case, on (b)(6) 2021, a patient was tested for hbsag with a reactive result of 1.92 s/co.The patient was then assigned to the hepatitis b group for gastroscopic testing.On (b)(6) 2021, the patient was again tested for hbsag with a non-reactive result of 0.00 s/co.No repeat testing was performed as required per product labeling instructions for the initial reactive hbsag result.Based on the information provided and abbott diagnostics¿ complaint investigation, alinity i hbsag, lot number 16422fn01, is performing as intended, no systemic issue or deficiency was identified.Section d3 suspect medical device was updated including the phone number, email, and fax number.Section g1 all manufacturers was updated including the mfg site email and mfg site fax number.

Manufacturer Narrative

This follow up is submitted to populate fields d8 and/or h6 with data that had previously been provided in field.H10.There is no change to the content of the data.

• Brand Name: ALINITY I HBSAG 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
• MDR Report Key: 11244966
• MDR Text Key: 252963857
• Report Number: 3008344661-2021-00029
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/18/2021
• Device Catalogue Number: 08P08-77
• Device Lot Number: 16422FN01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY I PROCESSING MODU, 03R65-01, AI04272; ALNTY I PROCESSING MODU, 03R65-01, AI04272; ALNTY I PROCESSING MODU, 03R65-01, AI04272
• Patient Outcome(s): Other