MAUDE Adverse Event Report: A.I.D.D LONGFORD ARCHITECT TOTAL B-HCG REAGENT KIT; SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN

Catalog Number 07K78-74

Device Problem False Negative Result (1225)

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

Event Date 12/17/2020

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer reported a false negative architect total b-hcg result for a (b)(6) year old female.The serum sample was tested, and the following results were provided (reference range: /= 25.00 miu/ml = positive): david colloidal gold test paper = weak positive architect i2000sr = < 1.20 miu/ml (negative).No impact to patient management was reported.

Manufacturer Narrative

The complaint investigation for false negative results for one patient when tested with the architect total b-hcg assay included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, field data review.Return testing was not completed as returns were not available.Complaint activity review associated with reagent lot 18139ui01 identified normal complaint activity.Trending review determined no trends were identified for the product.Device history record review 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 from customers worldwide and suggested that the performance of the lot is acceptable.Labeling was reviewed and found to adequately address the issue under review.Based on the investigation, no systemic issue or deficiency with the architect total b-hcg reagent lot 18139ui01 was identified.

• Brand Name: ARCHITECT TOTAL B-HCG REAGENT KIT
• Type of Device: SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
• Manufacturer (Section D): A.I.D.D LONGFORD; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• MDR Report Key: 11081510
• MDR Text Key: 241230931
• Report Number: 3005094123-2020-00291
• 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
• Report Date: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/08/2021
• Device Catalogue Number: 07K78-74
• Device Lot Number: 18139UI01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2000SR INST, 03M74-02, ISR63960; ARC I2000SR INST, 03M74-02, ISR63960
• Patient Age: 24 YR