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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/21/2022

Event Type  malfunction  

Event Description

The customer reported a false negative architect total b-hcg result on a 37-year-old female patient undergoing in vitro fertilization.Results provided: (b)(6) 2022= 126 miu/ml, new sample on (b)(6) 2022= <1.2 miu/ml, dilution = < 7000 miu/ml.Ultrasound revealed the gestational sac has not been developing recently.No impact to patient management was reported.

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 on a 37-year-old female patient undergoing in vitro fertilization.Results provided: (b)(6) 2022= 126 miu/ml, new sample on (b)(6) 2022= <1.2 miu/ml, dilution = < 7000 miu/ml.Ultrasound revealed the gestational sac has not been developing recently.No impact to patient management was reported.

Manufacturer Narrative

The complaint investigation for false negative architect total b-hcg results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history record review.Return testing was not completed as returns were not available.Trending review did not identify any trends for the issue for the product.Device history record review did not identify any non-conformances or deviations with lot number 28417ud02 and the complaint issue.Labeling was reviewed and sufficiently addresses the customer's issue.Based on our investigation, no systemic issue or deficiency with the architect total b-hcg assay for lot 28417ud02 was identified.Additional information in section d3 email and g1 manufacturer site email.

• 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
• Manufacturer (Section G): A.I.D.D LONGFORD; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 14335493
• MDR Text Key: 296166713
• Report Number: 3005094123-2022-00096
• Device Sequence Number: 1
• Product Code: DHA
• 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: 07/21/2022

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: 05/17/2022
• Device Catalogue Number: 07K78-74
• Device Lot Number: 28417UD02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/21/2022
• Initial Date FDA Received: 05/09/2022
• Supplement Dates Manufacturer Received: 07/21/2022
• Supplement Dates FDA Received: 07/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2021
• 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)
• Patient Age: 37 YR
• Patient Sex: Female