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

Catalog Number 07K78-35

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A followup report will be submitted when the evaluation is complete.

Event Description

The account generated a false negative architect total bhcg of <5 miu/ml with 1:10 dilution on a patient who initially tested >1500 miu/ml.The sample was repeated again with 1:10 dilution positive of 2233.71 miu/ml.No impact to patient management.Was reported.No specific patient information was provided.

Manufacturer Narrative

The account provided new additional information which makes the previously reported issue non-reportable.The account provided new information that the initial information provided was incorrect.The account did not generate a false negative architect total bhcg of <5 miu/ml with 1:10 dilution.The correct information is the account generated false depressed positive architect total bhcg of 13,021.28 miu/ml on a patient who repeated positive but a higher value of 98,254.07 miu/ml (1:15 dilution).No impact to patient management was reported.Based upon this new information, this complaint is no longer a reportable event.

• 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: 8467243
• MDR Text Key: 140477951
• Report Number: 3005094123-2019-00107
• Device Sequence Number: 1
• Product Code: DHA
• 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: 04/03/2019

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 Catalogue Number: 07K78-35
• Device Lot Number: 92046UI00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/21/2019
• Initial Date FDA Received: 03/29/2019
• Supplement Dates Manufacturer Received: 04/01/2019
• Supplement Dates FDA Received: 04/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR LIST 03M74-58; ARCHITECT I2000SR LIST 03M74-58; SERIAL (B)(4) ; SERIAL (B)(4)