MAUDE Adverse Event Report: A.I.D.D LONGFORD ARCHITECT TOTAL B-HCG REAGENT KIT; SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN

Model Number	7K78-30
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed a false positive architec b-hcg result generated on an architect i2000sr analyzer for one patient.A new sample was collected, and the result was negative.Both samples were repeated in duplicate on another architect analyzer and generated negative results.The following information was provided: sid (b)(6) initial result = 5051.93 miu/ml; repeat results on other architect ((b)(4)) = <1.20 miu/ml and <1.20 miu/ml.Sid (b)(6) initial result = <1.20 miu/ml; repeat results on other architect ((b)(4)) = <1.20 miu/ml and <1.20 miu/ml.There was no impact to patient management reported.
Additional Manufacturer Narrative
(b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, field data review, and inhouse testing of retained reagent kit lot 25512ud03, which contains the same bulk material and are identical with the likely cause lot except the labeling of the outer package.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.According to information provided the issue occurred due to pre-analysis problem, as the customer did not centrifuge correctly.Ticket trending review did not identify any trends for the likely cause.Device history review did not identify any non-conformances or deviations with the likely cause lot.The overall performance of architect total ss-hcg reagents in the field was reviewed using data gathered from customers worldwide.The median value of the negative patient population tested with the complaint lot is within the established limits and comparable to historical reagent lot performance, which confirms no systemic issue for the lot(s).In-house testing of retained reagent kit lot 25512ud03 was performed.All validity and acceptance criteria were met, demonstrating that the lot is performing acceptably.Based on the investigation, the architect b-hcg reagent lot 25512ud00 is performing as intended as the customer did not centrifuge correctly, no systemic issue or deficiency of the architect b-hcg reagent was identified.

• Brand Name: ARCHITECT TOTAL B-HCG REAGENT KIT
• Common Device Name: SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
• Manufacturer (Section D): A.I.D.D LONGFORD; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer (Section G): A.I.D.D LONGFORD; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford, IL N39 E-932 ; 2246682940
• MDR Report Key: 12816367
• Report Number: 3005094123-2021-00210
• Device Sequence Number: 14839915
• Product Code: DHA
• UDI-Device Identifier: 00380740014971
• UDI-Public: 00380740014971
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K983424
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2022

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: 02/23/2022
• Device Model Number: 7K78-30
• Device Catalogue Number: 07K78-35
• Device Lot Number: 25512UD00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/22/2021
• Supplement Date Received by Manufacturer: 01/13/2022
• Initial Report FDA Received Date: 11/15/2021
• Supplement Report FDA Received Date: 01/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARC I2000SR INST, 03M74-02, (B)(4); ARC I2000SR INST, 03M74-02, (B)(4)
• Patient Sex: Unknown