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 Misdiagnosis (2159)

Event Date 11/08/2020

Event Type  Injury  

Manufacturer Narrative

An evaluation is in process.A final report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.Patient identifier complete (b)(6).

Event Description

The customer reported a false negative architect total b-hcg on a (b)(6) yr old female patient.Results provided: (b)(6) 2020 (b)(6) = 1.93 iu/l.Patient redrawn on (b)(6) 2020 at another laboratory on dxi800 platform = 1531874 miu/ml, other results provided: progesterone = 45.24 nmol/l, ultrasound estimate( b)(6) pregnant.The patient was administered raceanisodamine hydrochloride intramuscular injection (1ml/10 mg) on (b)(6) 2020 following the negative b-hcg result.The patient self-administered a gi tract medicine (type unknown) on (b)(6) 2020.

Manufacturer Narrative

H6.Health effect impact code: f13.Component code: g01003.D8.Was this device service by a third party? no.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, and field data review.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 of the reagent lot was not able to be carried out as the lot 10179ui01 had expired.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.Return testing was not completed as returns were not available.A review of the product labeling concluded that the issue is sufficiently addressed.Based on our investigation, we have determined that there is no product deficiency with architect total b-hcg reagent lot 10179ui01.

Manufacturer Narrative

This follow up is submitted to populate fields d8 and/or h6 with data that had previously been provided in field h10.There is no change to the content of the data.

• 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: 11117309
• MDR Text Key: 231954734
• Report Number: 3005094123-2021-00003
• 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,Followup
• Report Date: 06/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2021
• Is this an Adverse Event Report?: Yes
• 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?: Yes
• Date Manufacturer Received: 06/15/2021
• 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); ARC I2000SR INST, 03M74-02, (B)(6)
• Patient Outcome(s): Other
• Patient Age: 25 YR