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

Catalog Number 07K78-30

Device Problem False Negative Result (1225)

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

Event Date 09/05/2017

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.(b)(6).

Event Description

The customer reports that one female patient had generated negative architect total b-hcg assay results on two different dates, (b)(6) 2017 (sid (b)(6); <1.2 miu/ml) and (b)(6) 2017 (sid (b)(6); <1.2 miu/ml).The patient had commented on both occasions that she had not had her period.The patient went to a different lab where a new sample was collected and a positive b-hcg result was generated.Also, the patient tested b-hcg positive with an over the counter pregnancy test.On two different dates, this patient had generated initial (b)(6) architect qual ii assay results of (b)(6) on (b)(6) 2017) and (b)(6), (sid (b)(6) on (b)(6) 2017).It was the low (b)(6) assay results that lead the patient to consult a specialist who discovered the pregnancy by an ultrasound (performed on (b)(6) 2017) and verified that the patient was (b)(6) months pregnant.The patient has been diagnosed with a bipartite uterus and an at risk pregnancy.(b)(6) results were (b)(6).There is no impact to patient management reported.

Manufacturer Narrative

A review of complaint tracking and trending metrics was performed and identified no adverse trends or systemic issues in conjunction with the complaint incident currently under evaluation.The historical performance of reagent lot 70091ui00 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 70091ui00 is within the established control limits.Therefore, no unusual reagent lot performance was identified for lot 70091ui00.In addition, a device history record review was performed on lot 70091ui00, which did not show any potential non-conformances, deviations, or non-conformances.The architect total b-hcg assay package insert and the architect system operations manual provide information to address the current customer issue.Based on the available information from the customer site and the results of this evaluation, there is no evidence to reasonably suggest that a systemic issue or product deficiency exists.

• 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: 7157811
• MDR Text Key: 96708249
• Report Number: 3005094123-2018-00002
• 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: 02/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2017
• Device Catalogue Number: 07K78-30
• Device Lot Number: 70091UI00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/21/2018
• 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)(4); LN: 03M74-02 SN: (B)(4)