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

Catalog Number 07K78-25

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/04/2019

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer stated that false negative architect total bhcg results of <1.20 miu/ml were generated for a patient that tested positive at 114, 84 and 87 miu/ml using an alternate method.No adverse impact to patient management was reported.

Manufacturer Narrative

Section d11.Concomitant medical products- the concomitant product was inadvertently left out of the previous submission.This section has been updated with the following information: architect i2000sr analyzer; list 03m74-02; sn (b)(6).Review of complaint activity determined there was normal complaint activity for the likely cause lot 92571ui00.Tracking and trending report review for the architect total b-hcg assay identified a non-statistical trend.Testing was performed using a retained kit and all specifications were met.Product quality history review for lot 92571ui00 did not identify any issues.The historical performance of reagent lots was evaluated using worldwide field data; the patient median result for lot 92571ui00 was comparable with all other lots in the field within established baselines.Labeling was reviewed and sufficiently addresses the customer's issue.Based on the investigation no systemic issue or deficiency of the architect total b-hcg assay 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 NA ; EI NA
• MDR Report Key: 8664055
• MDR Text Key: 147055128
• Report Number: 3005094123-2019-00169
• 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: 07/24/2019

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: 10/08/2019
• Device Catalogue Number: 07K78-25
• Device Lot Number: 92571UI00
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/04/2019
• Initial Date FDA Received: 06/03/2019
• Supplement Dates Manufacturer Received: 07/22/2019
• Supplement Dates FDA Received: 07/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR ANALYZER; LIST 03M74-02, SN (B)(6)