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

Model Number	7K78-35
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A followup report will be submitted when the evaluation is complete.
Event or Problem Description
The account generated false positive architect bhcg on a patient that did not match the clinical history.On (b)(6) 2017, id 7672024 generated architect bhcg positive of 203.8 and 173.23 (no unit of measurement was provided).A few days later the same sample was tested again with the same positive architect bhcg results (200 and 173).On (b)(6) 2017 new samples were obtained and tested architect bhcg negative (<1.2 and <1.2).No impact to patient management was reported.
Additional Manufacturer Narrative
The customer's instrument logs were reviewed for the samples tested in september.This review did not identify conclusive information to indicate an instrument and/or sample integrity/handling issue occurred.To investigate the customer's issue the historical performance of reagent lot 76054ui00 was evaluated using world wide data.The patient data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result for lot 76054ui00 is within the established control limits.Therefore, no unusual reagent lot performance was identified for lot 76054ui00.In addition, a device history record review was performed on lot 76054ui00, which did not show any potential non-conformances, deviations, or non-conformances.Review of the ticket trending and lot search did not identify an increase in complaint activity related to false elevated/positive results.Labeling was reviewed and found to adequately address the issue under review.No product deficiency was identified.

• Brand Name: ARCHITECT TOTAL B-HCG
• Common Device Name: B-HCG
• Manufacturer (Section D): A.I.D.D LONGFORD; lisnamuck; co. longford; longford NA ; EI NA
• MDR Report Key: 6911316
• Report Number: 3005094123-2017-00062
• Device Sequence Number: 13482037
• Product Code: DHA
• UDI-Device Identifier: 00380740106003
• UDI-Public: (01)00380740106003(17)180421(10)76054UI00
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K983424
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/21/2018
• Device Model Number: 7K78-35
• Device Catalogue Number: 07K78-35
• Device Lot Number: 76054UI00
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/08/2017
• Supplement Date Received by Manufacturer: 11/08/2017
• Initial Report FDA Received Date: 10/03/2017
• Supplement Report FDA Received Date: 12/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 16 YR