MAUDE Adverse Event Report: A.I.D.D LONGFORD ARCHITECT TOTAL B-HCG REAGENT KIT

Catalog Number 07K78-74

Device Problem False Negative Result (1225)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/31/2020

Event Type  malfunction  

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.This report is being filed on an international product, list number 07k78-74, that has a similar product distributed in the us, list number 07k78-25.

Event Description

The customer observed a false negative architect total b-hcg result for one patient.The following data was provided (<5.00 miu/ml is negative, >/=25.00 miu/ml is positive): initial result was 4.65 miu/ml, repeats were 128.76 miu/ml, 155.02 miu/ml, 200.71 miu/ml, and 298.00 miu/ml.There was no impact to patient management reported.

Manufacturer Narrative

Section d4 - lot no.Changed from 10179ui00 to 10179ui01.

Manufacturer Narrative

The complaint investigation for a falsely elevated architect total b-hcg result 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 review for the complaint lot.Trending review determined no related trend for the product.Manufacturing documentation for the likely cause lot was reviewed and did not identify any issues.Device history record review on lot number 10179ui00 did not identify any non-conformances or deviations with the likely cause lot.The overall performance of architect total b-hcg reagents in the field was reviewed using data gathered via abbottlink from customers worldwide and suggested that the performance is acceptable.No systemic issue or deficiency of the architect total b-hcg assay was identified.Based on the information provided and abbott diagnostics¿ complaint investigation, no systemic issue or deficiency of architect total b-hcg, lot number 10179ui00, was identified.

Manufacturer Narrative

The complaint investigation for a falsely decreased architect total b-hcg result 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 review for the complaint lot.Trending review determined no related trend for the product.Manufacturing documentation for the likely cause lot was reviewed and did not identify any issues.Device history record review on lot number 10179ui00 did not identify any non-conformances or deviations with the likely cause lot.The overall performance of architect total b-hcg reagents in the field was reviewed using data gathered via abbottlink from customers worldwide and suggested that the performance is acceptable.No systemic issue or deficiency of the architect total b-hcg assay was identified.Based on the information provided and abbott diagnostics¿ complaint investigation, no systemic issue or deficiency of architect total b-hcg, lot number 10179ui00, was identified.Upon further review, section h10 - addtl mfg narrative was updated from, "the complaint investigation for a falsely elevated architect total b-hcg result." to "the complaint investigation for a falsely decreased architect total b-hcg result.".

• Brand Name: ARCHITECT TOTAL B-HCG REAGENT KIT
• Type of Device: ARCHITECT TOTAL B-HCG
• Manufacturer (Section D): A.I.D.D LONGFORD; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• MDR Report Key: 10518600
• MDR Text Key: 228840068
• Report Number: 3005094123-2020-00203
• Device Sequence Number: 1
• Product Code: DHA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/11/2020
• Device Catalogue Number: 07K78-74
• Device Lot Number: 10179UI01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/25/2020
• 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) ; ARC I2000SR INST, 03M74-02, (B)(6) ; ARCHITECT I2000SR PROCESSING MODULE,; LIST# 03M74-02, SERIAL# (B)(6)