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 11/25/2020

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 false negative architect total b-hcg results on a (b)(6) year-old patient.On (b)(6) 2020, the patient sample generated a total b-hcg result of 0.04 miu/ml (<5.00 miu/ml = negative).On (b)(6) 2020, a color ultrasound found that the patient was three months pregnant.The laboratory department retested the sample from the (b)(6) and found that the b-hcg result was >150000 miu/ml (>25 miu/ml = positive).After calibration, the patient sample was retested again, and the results were b-hcg >150000 miu/ml.No impact to patient management was reported.

Manufacturer Narrative

The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labelling review, device history record review, field data review.Return testing was not completed as returns were not available.The ticket search determined normal complaint activity for the issue for the product.A review of tracking and trending did not identify any trends for the complaint issue.Device history record review did not identify any issues associated with the complaint lot.The overall performance of architect total b-hcg reagents was reviewed using worldwide field data and suggested that the performance of the lot is acceptable.Additionally, labeling review concluded that the issue is adequately addressed.Based on the investigation, no systemic issue or deficiency of the architect total b-hcg reagent lot 10179ui01 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: 10969809
• MDR Text Key: 241231226
• Report Number: 3005094123-2020-00276
• 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: 12/08/2020
• 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: 02/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2000SR INST, 03M74-02, ISR55982; ARC I2000SR INST, 03M74-02, ISR55982