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 No Known Impact Or Consequence To Patient (2692)

Event Date 12/09/2020

Event Type  malfunction  

Manufacturer Narrative

Patient identifier: multiple = sid (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer reported that a clinician questioned false positive architect total b-hcg results on a (b)(6) year-old female patient diagnosed with irregular menstruation.On (b)(6) 2020, the initial result for sid (b)(6) was 2015.59 miu/ml; the patient tested negative for urine hcg; on (b)(6) 2020 the retest sid (b)(6) generated a result of <1.20 miu/ml.Three days later the patients period started, and the retested b-hcg result was normal at another hospital.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 and in house testing of retained kits with the complaint lot number.Return testing was not completed as returns were not available.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.Labeling was reviewed and found to adequately address the current issue.In house testing determined that the specificity performance is acceptable.The overall performance of architect total hcg reagents was reviewed using worldwide field data and suggested that the performance of the lot is acceptable.Based on the investigation, no systemic issue or product deficiency for the architect total b-hcg reagent lot 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: 11056861
• MDR Text Key: 223180611
• Report Number: 3005094123-2020-00288
• 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: 02/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: No
• 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: 12124UI00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2000SR INST, 03M74-02, ISR60044; ARC I2000SR INST, 03M74-02, ISR60044; ARC I2000SR INST, 03M74-02, ISR60044
• Patient Age: 36 YR