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 Known Impact Or Consequence To Patient (2692)

Event Date 01/14/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported a false negative architect total b-hcg result.Sample id (b)(6) generated an initial result of <1.20 miu/ml and retest generated 3864 miu/ml.A new sample (b)(6) from the same patient generated 7992 miu/ml.No impact to patient management was reported.

Manufacturer Narrative

Review of complaint activity determined that there was normal complaint activity for the likely cause lot 92571ui00.Tracking and trending report review for the architect total b-hcg assay determined that there were no related adverse trends, however, a non-statistical trend was identified associated with the complaint issue.Return testing was not completed as returns were not available.The historical performance in the field of reagent lot 92571ui00 using worldwide field data was performed.The patient median result for the lot was analyzed and found to be comparable to all other lots in the field and within established limits, confirming no systematic issue for the lot.Manufacturing documentation for the likely cause lot did not identify any issues associated with the complaint issue.Additionally, labeling was reviewed and sufficiently addresses the customer's issue.Based on the available information, 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: 8363308
• MDR Text Key: 136920930
• Report Number: 3005094123-2019-00064
• 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: 04/17/2019

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: 02/05/2019
• Initial Date FDA Received: 02/22/2019
• Supplement Dates Manufacturer Received: 04/01/2019
• Supplement Dates FDA Received: 04/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I1000SR ANALYZER, LN 01L86-40; ARCHITECT I1000SR ANALYZER, LN 01L86-40; SERIAL I1SR02464; SERIALI1SR02464; ARCHITECT I1000SR ANALYZER, LN 01L86-40; SERIAL (B)(4)