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

Model Number 7K78-25

Device Problem False Negative Result (1225)

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

Event Date 06/27/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer observed false negative architect b-hcg results for one sample that was questioned by the physician as the patient is pregnant.The following data was provided: 22178003505a initial result was <1.2 miu/ml, repeat was <1.2 miu/ml, repeat with 1:15 dilution was <7000 miu/ml another sample was drawn and generated the same results.The patient was in the er and is around 5 weeks pregnant.The er physician was able to hear the fetal heartbeat.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, device history record review, and inhouse testing.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 for lot 32494ud00 and the complaint issue.Accuracy testing was completed using panels which mimic patient samples using an in-house retained kit stored at the recommended storage condition.All specifications were met indicating that the lot is performing acceptably.Labeling was reviewed and found to be adequate.Based on the available information, no systemic issue or deficiency of the architect total b-hcg, lot number 32494ud00 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
• 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: 15040026
• MDR Text Key: 297230829
• Report Number: 3005094123-2022-00148
• Device Sequence Number: 1
• Product Code: DHA
• UDI-Device Identifier: 00380740014964
• UDI-Public: 00380740014964
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K983424
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/16/2022

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: 10/21/2022
• Device Model Number: 7K78-25
• Device Catalogue Number: 07K78-25
• Device Lot Number: 32494UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/27/2022
• Initial Date FDA Received: 07/18/2022
• Supplement Dates Manufacturer Received: 08/12/2022
• Supplement Dates FDA Received: 08/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I1000SR INTGR, 01L86-40, (B)(6) ; ARC I1000SR INTGR, 01L86-40, (B)(6)