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 09/07/2023

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A final report will be submitted when the evaluation is complete.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.

Event Description

The customer observed false non-reactive alinity i anti-hbc ii results generated for a patient sample.The following data was provided: sample id (b)(6).Initial result = 0.84 s/co (negative), repeat result on another alinity instrument = 0.80 s/co (negative), repeat on roche = 0.844 s/co, 0.85 s/co, 0.863 s/co (positive).Additional results provided: hbsag initial result = 28.78 s/co, repeat on siemens platform = 43.38 s/co, repeat on roche = 15.60 s/co.No impact to patient management was reported.

Manufacturer Narrative

Update: additional information in section d4 - expiration date updated from blank to 3/15/2024, and section h4 - device mfg date updated from balnk to 4/13/2023 the complaint investigation 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 testing of a retained reagent kit lot 50530be00.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.The ticket search by lot indicates that the complaint lot performs as expected for this product.Ticket trending review did not identify any trends for complaint lot.Device history review did not identify any non-conformances or deviations with the complaint lot.In-house testing was completed using panels which mimic patient samples using an in-house retained kit.All specifications were met indicating the lot is performing acceptably.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the alinity i anti-hbc ii reagent lot 50530be00 was identified.Corrected information in multiple sections of g1: contact office address 1, contact office city, contact office postal code, contact office email, contact office country, contact office first name, contact office last name, contact office phone number, contact office fax number.

Event Description

The customer observed false non-reactive alinity i anti-hbc ii results generated for a patient sample.The following data was provided: sample id (b)(6) initial result = 0.84 s/co (negative), repeat result on another alinity instrument = 0.80 s/co (negative), repeat on roche = 0.844 s/co, 0.85 s/co, 0.863 s/co (positive).Additional results provided: hbsag initial result = 28.78 s/co, repeat on siemens platform = 43.38 s/co, repeat on roche = 15.60 s/co no impact to patient management was reported.

• 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: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 17814477
• MDR Text Key: 324256190
• Report Number: 3002809144-2023-00408
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• Reporter Country Code: VM
• 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: 11/08/2023

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: 03/15/2024
• Device Catalogue Number: 07P87-22
• Device Lot Number: 50530BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/07/2023
• Initial Date FDA Received: 09/25/2023
• Supplement Dates Manufacturer Received: 11/06/2023
• Supplement Dates FDA Received: 11/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2023
• 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); ALNTY I PROCESSING MODU, 03R65-01, (B)(6); ALNTY I PROCESSING MODU, 03R65-01, (B)(6); ALNTY I PROCESSING MODU, 03R65-01, (B)(6); ALNTY I PROCESSING MODU, 03R65-01, (B)(6)