MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT HAVAB-G REAGENT KIT; HEPATITIS A TEST (ANTIBODY AND IGM ANTIBODY)

Model Number	6L27-25
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer stated that a false reactive architect havab-g result was generated for a patient sample on (b)(6) 2022.The sample initially tested nonreactive at 0.03 s/co.The sample retested reactive at 1.01 s/co two days later on a different architect analyzer.The false reactive result was not reported out of the laboratory.No impact to patient management was reported.
Additional 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.
Additional Manufacturer Narrative
Trending review determined no trend for the issue for the product.Historical complaint review determined no trend in 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.The overall performance of alinity i havab-g reagents in the field was reviewed using data gathered via abbottlink from customers worldwide.Standard deviation to cutoff for the negative population and median values (for the negative population) for the complaint lot(s) are within the established limits and comparable to the historical reagent lot performance.Based on the investigation, no deficiency for lot number 24882be00 was identified.

• Brand Name: ARCHITECT HAVAB-G REAGENT KIT
• Common Device Name: HEPATITIS A TEST (ANTIBODY AND IGM ANTIBODY)
• 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: 15847388
• Report Number: 3002809144-2022-00407
• Device Sequence Number: 5202048
• Product Code: LOL
• UDI-Device Identifier: 00380740011185
• UDI-Public: 00380740011185
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K113704
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/01/2023
• Device Model Number: 6L27-25
• Device Catalogue Number: 06L27-25
• Device Lot Number: 24882BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/28/2022
• Supplement Date Received by Manufacturer: 12/13/2022
• Initial Report FDA Received Date: 11/22/2022
• Supplement Report FDA Received Date: 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARC I2000SR INST, 03M74-02, ISR64328; ARC I2000SR INST, 03M74-02, ISR64328
• Patient Sex: Unknown