MAUDE Adverse Event Report: ABBOTT GMBH ALINITY S ANTI-HBC REAGENT KIT; HEPATITIS B VIRUS CORE ANTIGEN (E COLI, RECOMBINANT)

Catalog Number 06P06-60

Device Problem False Positive Result (1227)

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

Event Date 03/02/2023

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow up report will be submitted when the evaluation is complete.Section a1 patient identifier sids: (b)(6) 2023 (b)(6), (b)(6)2023 (b)(6) (b)(6) 2023 sid (b)(6) see mr# 3002809144-2023-00450 for other lot#.

Event Description

The customer reported a false reactive alinity s anti-hbc result on a donor.In (b)(6) 2023 alinity was reactive; in (b)(6) 2023 was nonreactive; in (b)(6) 2023 was reactive, another laboratory was negative for anti-hbc.Results provided: (b)(6) 2023 sid (b)(6) = 1.06 / 1.06 / 1.06 s/co.(b)(6) sid (b)(6)= 0.84 s/co.(b)(6) sid (b)(6) = 1.05 / 1.02 / 1.02 s/co.No impact to donor management was reported.

Manufacturer Narrative

A complaint investigation for false nonreactive results for alinity s anti-hbc included a review of trending data, labeling, device history record, field data, and a complaint search.No customer returns were available for evaluation.The complaint data for the product identified normal complaint activity for the complaint issue and no trends were identified.Labeling review concluded the labeling adequately addresses the issue.A device history record review did not identify any non-conformances or deviations.Based on the results of this investigation, alinity s anti-hbc reagent, lot 49219be00 is performing as expected and no systemic issue or product deficiency was identified.

Event Description

The customer reported a false reactive alinity s anti-hbc result on a donor.In (b)(6) 2023 alinity was reactive; in (b)(6) 2023 was nonreactive; in (b)(6) 2023 was reactive, another laboratory was negative for anti-hbc.Results provided: (b)(6) 2023 sid (b)(6) = 1.06 / 1.06 / 1.06 s/co, (b)(6) 2023 sid (b)(6) = 0.84 s/co, (b)(6) 2023 sid (b)(6) = 1.05 / 1.02 / 1.02 s/co.No impact to donor management was reported.

• Brand Name: ALINITY S ANTI-HBC REAGENT KIT
• Type of Device: HEPATITIS B VIRUS CORE ANTIGEN (E COLI, RECOMBINANT)
• 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: 18067586
• MDR Text Key: 327315306
• Report Number: 3002809144-2023-00457
• Device Sequence Number: 1
• Product Code: QHM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BL125681
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/08/2023

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: 04/05/2024
• Device Catalogue Number: 06P06-60
• Device Lot Number: 49219BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2023
• Initial Date FDA Received: 11/03/2023
• Supplement Dates Manufacturer Received: 12/07/2023
• Supplement Dates FDA Received: 12/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY S SYSTEM, 06P16-01, (B)(6) ; ALNTY S SYSTEM, 06P16-01, (B)(6)