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 Positive Result (1227)

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

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer generated a false positive architect total b-hcg result for one patient.The following data was provided: sid (b)(6) - (b)(6) 2020 initial result 2382 miu/ml (positive); alternate method (time resolution) positive.Sid (b)(6) - (b)(6) 2020 new draw <1.2 miu/ml (negative).Sid (b)(6) - (b)(6) 2020 original draw retested 8.28 miu/ml (positive).The patient is an (b)(6) year old female with a history of hepatitis b and (b)(6).The sample from (b)(6) 2020 was noted as being lipemic.No impact to patient management was reported.

Manufacturer Narrative

H6 health effect impact code: f26.Component code: g01003.D8 was this device serviced by a third party? unknown.A review of tickets was performed for reagent lot number 10179ui01.The ticket search determined that there is elevated complaint activity for the reagent lot.A review of tracking and trending did not identify any trends for the complaint issue.Return testing was not completed as returns were not available.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.A review of labeling concluded that the issue is sufficiently addressed.Based on the investigation no systemic issue or deficiency of the architect total b-hcg reagent lot 10179ui01 was identified.

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: 11032899
• MDR Text Key: 241231087
• Report Number: 3005094123-2020-00285
• 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: 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• 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: 10179UI00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2000SR INST, 03M74-02, ISR53157; ARC I2000SR INST, 03M74-02, ISR53157; ARC I2000SR INST, 03M74-02, ISR53157
• Patient Age: 18 YR