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 Positive Result (1227)

Patient Problem Misdiagnosis (2159)

Event Date 11/09/2020

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.

Event Description

The customer reported false positive architect total b-hcg results on a (b)(6)year old female patient who was diagnosed with ectopic pregnancy.Results provided for this architect analyzer, reagent lot 12124ui03: (b)(6) 2020 sid (b)(6) = 1214.11 miu / ml, (b)(6) 2020 ¿ sid (b)(6) = 991.33 miu / ml, (b)(6) 2020 ¿ sid (b)(6) = 987.01 miu / ml.Results on a different architect analyzer, reagent lot 18139ui00: (b)(6) 2020 sid (b)(6) = 1318.89 iu/l, (b)(6) 2020 sid (b)(6) = 1464.63 iu/l, (b)(6) 2020 sid (b)(6)= 1377.53 iu/l, (b)(6) 2020 sid (b)(6) = 1522.88 iu/l, (b)(6) 2020 sid (b)(6) = 1520.55 iu/l.Test performed at another laboratory = negative; sample from (b)(6) 2020 tested on the advia centaur = negative.A d&c was performed on (b)(6) 2020 due to the false positive architect results.A diagnostic laparoscopy was performed on (b)(6) 2020 which confirmed the patient did not have an ectopic pregnancy.

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 and in house testing of retained kits with the complaint lot number.Return testing was not completed as returns were not available.Trending review determined no trends for the product.Device history record review did not identify any non-conformances or deviations with the likely cause lot.In house testing determined that the accuracy performance is not negatively impacted.The overall performance of architect total b-hcg reagents in the field was reviewed using data gathered via abbottlink from customers worldwide and suggested that the performance of the lot is acceptable.Based on the investigation, it was determined that there is no a systemic issue or product deficiency with architect total b-hcg reagent lot 12124ui03.

• 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: 10971882
• MDR Text Key: 221786417
• Report Number: 3005094123-2020-00278
• 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: 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/21/2021
• Device Model Number: 7K78-25
• Device Catalogue Number: 07K78-25
• Device Lot Number: 12124UI03
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/26/2020
• Initial Date FDA Received: 12/08/2020
• Supplement Dates Manufacturer Received: 02/08/2021
• Supplement Dates FDA Received: 02/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 45 YR