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

Model Number 7K78-25

Device Problem False Positive Result (1227)

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

Event Date 08/24/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer observed a false positive architect total b-hcg result for one sample.The following data was provided: sid: (b)(6); on (b)(6) 2020; initial result = 727.64 miu/ml (positive).A new sample was collected on (b)(6) 2020, was <1.2 miu/ml (negative).The original sample was repeated with a result = <1.2 miu/ml (negative).No impact to patient management was reported.

Manufacturer Narrative

The complaint investigation for false positive results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, field data review and inhouse testing.Return testing was not completed as returns were not available.A review of tracking and trending did not identify any trends for the product.Device history record review did not identify any non-conformances or deviations with the likely cause lot.Inhouse testing was completed for the complaint lot.All validity and acceptance criteria were met demonstrating that the lot is performing acceptably.The overall performance of architect total b-hcg reagents was reviewed using field data gathered from customers worldwide and suggested that the performance of the lot is acceptable.Based on our investigation, no systemic issue or deficiency of the architect total b-hcg for reagent lot 08042ui00 was identified.

• Brand Name: ARCHITECT TOTAL B-HCG
• Type of Device: B-HCG
• Manufacturer (Section D): A.I.D.D LONGFORD; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• MDR Report Key: 10480765
• MDR Text Key: 214342181
• Report Number: 3005094123-2020-00195
• 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: 11/18/2020

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: 09/20/2020
• Device Model Number: 7K78-25
• Device Catalogue Number: 07K78-25
• Device Lot Number: 08042UI00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/26/2020
• Initial Date FDA Received: 09/01/2020
• Supplement Dates Manufacturer Received: 11/06/2020
• Supplement Dates FDA Received: 11/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I1000SR MOD, 01L86-01, I1SR53999.; ARCHITECT I1000SR PROCESSING MODULE.; LIST 01L86-01, SERIAL (B)(6).