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

Catalog Number 06C29-27

Device Problem False Positive Result (1227)

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

Event Date 12/02/2021

Event Type  malfunction  

Event Description

The customer observed false reactive architect havab-igg results for one patient.The following data was provided (>/= to 1.00 s/co is reactive): 15dec2021 sid (b)(6) initial havab igg result was (b)(6) s/co (reactive), repeated (b)(6) s/co (nonreactive) (lot 31400be00) no impact to patient management was reported.

Manufacturer Narrative

Patient identifier = sid (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Manufacturer Narrative

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 reagent lots perform as expected for this product.Return testing was not performed as returns were not available.Trending review did not identify any trends for the complaint issue.Device history record review was performed on lot number 31400be00, which did not show any potential non-conformances, deviations, or non-conformances.The overall performance of architect havab igg reagents was reviewed using worldwide field data.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.Labeling review concludes that the issue is adequately addressed.Based on all reviewed data, we conclude that there is no general issue with the architect havab igg reagent lots identified in this complaint.

• Brand Name: ARCHITECT HAVAB-G REAGENT KIT
• Type of Device: 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 ; 433331157
• MDR Report Key: 13370732
• MDR Text Key: 285254891
• Report Number: 3002809144-2022-00026
• Device Sequence Number: 1
• Product Code: LOL
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 03/08/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 08/13/2022
• Device Catalogue Number: 06C29-27
• Device Lot Number: 31400BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2022
• Initial Date FDA Received: 01/27/2022
• Supplement Dates Manufacturer Received: 02/16/2022
• Supplement Dates FDA Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2SR REFURB-SEKAT, 03M74-97, ISR03119; ARC I2SR REFURB-SEKAT, 03M74-97, ISR03119