MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION LONGFORD ARCHITECT TOTAL B-HCG

Model Number 7K78-30

Device Problem False Negative Result (1225)

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

Event Date 03/29/2020

Event Type  malfunction  

Manufacturer Narrative

Patient identifier = sid (b)(6).There was no further patient information 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 false negative architect total bhcg results on multiple patients.The results were provided: sid (b)(6) initial b-hcg result=<1.20 iu/l (negative)/repeated result=<1.20 iu/l(

Manufacturer Narrative

An investigation was performed for the customer issue and included a review of the complaint text, troubleshooting, a search for similar complaints, instrument service history review, and a review of product labeling.A review of tickets was performed for architect total b-hcg reagent lot number 03333ui00.The ticket search found no complaints similar to this issue.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.To evaluate the performance of the assay, an internal panel was tested with retained kits of the reagent lot.All specifications were met indicating that the lot is performing acceptably.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 assay lot number 03333ui00 was identified.

• Brand Name: ARCHITECT TOTAL B-HCG
• Type of Device: B-HCG
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION LONGFORD; lisnamuck; co. longford; longford NA ; EI NA
• MDR Report Key: 9937477
• MDR Text Key: 226763296
• Report Number: 3005094123-2020-00085
• Device Sequence Number: 1
• Product Code: DHA
• UDI-Device Identifier: 00380740014971
• UDI-Public: 00380740014971
• 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: 05/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/16/2020
• Device Model Number: 7K78-30
• Device Catalogue Number: 07K78-30
• Device Lot Number: 03333UI00
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR ANALYZER; ARCHITECT I2000SR ANALYZER; LN 03M74-02, SN (B)(6) ; LN 03M74-02, SERIAL (B)(6)