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

Catalog Number 07K78-25

Device Problem False Negative Result (1225)

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

Event Date 04/18/2019

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.There is no further patient information provided by the customer.

Event Description

The customer reported false negative architect b-hcg results on one patient.The results provided were: (b)(6) 2019 sid (b)(6) = 1.2miu/ml (/=25.00miu/ml = positive).There was no reported impact to patient management.

Manufacturer Narrative

After further evaluation, the suspect medical device was changed from architect total b-hcg, list number 07k78-25, and a.I.D.D longford, lisnamuck, co.Longford, longford na, irl manufacturing site in section d of this report to architect i2000sr analyzer, list number 03m74-02, serial # isr51334, and abbott manufacturing inc, 1921 hurd drive, irving, tx 75038, usa manufacturing site.Mdr number 1628664-2019-00453 has been submitted and all further information will be documented under that mdr number.

• Brand Name: ARCHITECT TOTAL B-HCG
• Type of Device: B-HCG
• Manufacturer (Section D): A.I.D.D LONGFORD; lisnamuck; co. longford; longford NA ; EI NA
• MDR Report Key: 8605384
• MDR Text Key: 144982011
• Report Number: 3005094123-2019-00144
• Device Sequence Number: 1
• Product Code: DHA
• UDI-Device Identifier: 00380740014964
• UDI-Public: 00380740014964
• Combination Product (y/n): N
• PMA/PMN Number: K983424
• 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: 06/25/2019

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: 12/19/2019
• Device Catalogue Number: 07K78-25
• Device Lot Number: 95261UI00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/22/2019
• Initial Date FDA Received: 05/13/2019
• Supplement Dates Manufacturer Received: 06/03/2019
• Supplement Dates FDA Received: 06/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR ANALYZER, LIST # 03M74-02; ARCHITECT I2000SR ANALYZER, LIST # 03M74-02; SERIAL # ISR51334; SERIAL # ISR51334