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

Catalog Number 06C29-75

Device Problems False Positive Result (1227); High Test Results (2457)

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

Event Date 05/25/2023

Event Type  malfunction  

Event Description

The customer observed false reactive architect havab-igg results which does not match with clinical picture on several pediatric patients.The results provided were: (b)(6).There was no reported impact to patient management.

Manufacturer Narrative

This report is being filed on an international product, list number 6c29 that has a similar product distributed in the us, list number 6l27.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed false reactive architect havab-igg results which does not match with clinical picture on several pediatric patients.The results provided were: patient 1: 3yrs old male initial=5.29 s/co (> or =1.00 s/co=reactive) patient 2: 4yrs old female initial=7.50 s/co patient 3: 4yrs old male initial=10.10 s/co patient 4: 3yrs old initial=10.08 s/co patient 5: 3yrs old female initial=8.77 s/co there was no reported impact to patient management.

Manufacturer Narrative

The complaint evaluation 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 field data of architect havab-igg reagent lot number 43737be01.The ticket search determined that there is as expected complaint activity for the likely cause lot.The ticket trending review of at least 12 months complaint data for the likely cause list number does not identify any adverse or non-statistical trend.The tracking and trending report review determined that there are no adverse trends.Return testing was not completed as returns were not available.Historical performance of reagent lot 43737be01 was evaluated using worldwide data from abbottlink.The median value of the negative patient population for the complaint lot is within the established limits and comparable to historical reagent lot performance.All field data demonstrating that the lot is performing as expected.Device history record review did not identify any non-conformances or deviations with the complaint lot and complaint issue.A review of the manufacturing documentation did not identify any issues associated with the customer¿s observation.There was no issue with reagent performance identified.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the architect havab-igg reagent lot number 43737be01.Correction to section h6: medical device problem code updated from (b)(4)(incorrect) to (b)(4)(correct).

• Brand Name: ARCHITECT HAVAB-IGG 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 ; EI N39 E932 ; 433331157
• MDR Report Key: 17064703
• MDR Text Key: 316589002
• Report Number: 3002809144-2023-00259
• Device Sequence Number: 1
• Product Code: LOL
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 06/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/08/2023
• Device Catalogue Number: 06C29-75
• Device Lot Number: 43737BE01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2000SR INST, 03M74-02, (B)(6); ARC I2000SR INST, 03M74-02, (B)(6)