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	08/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All available patient information was included.Additional patient details are not available.The complaint investigation for a false reactive sample tested with the architect total b-hcg assay 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 kits with the complaint lot number.Trending review determined no adverse trend for the issue for the product.Device history record review did not identify any non-conformances or deviations for the likely cause lot and complaint issue.Field data review using data gathered via abbottlink from customers worldwide and inhouse testing of a retained kit suggested that the performance of the lot is as expected.Based on the investigation, no systemic issue or deficiency with the architect total b-hcg reagent lot was identified.
Event or Problem Description
The customer stated that a positive architect total b-hcg result of 46.71 miu/ml was generated on (b)(6) 2021 for a (b)(6) year old female patient.The same patient tested negative using the roche b-hcg method on (b)(6) 2021.The sample from (b)(6) 2021 was retested and the architect total b-hcg result was 17.29 miu/ml (grayzone).A positive result was generated using an alternate method (colloidal gold method).The patient's clinical diagnosis is bilateral hydrosalpinx.No adverse impact to patient management was reported.

• 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
• MDR Report Key: 12474554
• Report Number: 3005094123-2021-00173
• Device Sequence Number: 3891443
• Product Code: DHA
• UDI-Device Identifier: 00380740014971
• UDI-Public: 00380740014971
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K983424
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/15/2021

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: 11/23/2021
• Device Model Number: 7K78-30
• Device Catalogue Number: 07K78-77
• Device Lot Number: 22493UI03
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/26/2021
• Initial Report FDA Received Date: 09/15/2021
• 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, ISR62968
• Patient Age: 26 YR