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	05/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter name and address: (b)(6).The complaint investigation for false elevated result for one patient when 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 in-house testing of retained kits with the complaint lot number.Return testing was not completed as returns were not available.Trending review determined no trends identified for the product.Device history record review did not identify any non-conformances or deviations with the likely cause lot.The overall performance of architect total b-hcg reagents in the field was reviewed using data gathered via customers worldwide and determined that the performance of the lot is acceptable.In-house testing was performed with retained kit lots of the complaint lot number 21034ui00 and determined that the specificity performance is not negatively impacted.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or deficiency with the architect total b-hcg reagent lot 21034ui00 was identified.
Event or Problem Description
The customer reported a false positive architect total b-hcg result for a patient.On (b)(6) 2021, sid (b)(6) generated a positive b-hcg result of 14921.66 iu/l.The doctor contacted the customer to advise them that this patient was not pregnant and the positive b-hcg result does not correlate with the patients history.The patient also had an ultrasound performed which confirms the patient was not pregnant at the time the sample was tested.A repeat sample was sent to another provider and run on a different platform which generated a negative result.There was no impact to patient management 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: 12170955
• Report Number: 3005094123-2021-00133
• Device Sequence Number: 887578
• Product Code: DHA
• UDI-Device Identifier: 00380740014971
• UDI-Public: 00380740014971
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 07/14/2021

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: 10/01/2021
• Device Model Number: 7K78-30
• Device Catalogue Number: 07K78-30
• Device Lot Number: 21034UI00
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/23/2021
• Initial Report FDA Received Date: 07/14/2021
• 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, (B)(4)