MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ARCHITECT TOTAL B-HCG REAGENT KIT; SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN

Catalog Number	07K78-25
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed false negative architect total b-hcg results that were inconsistent with clinical picture on (b)(6) 2024.The customer retested on (b)(6) 2024 and the results were positive, which was aligned with the patient¿s clinical observation.No impact to patient management was reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information has been included.No additional patient details are available.
Additional Manufacturer Narrative
After further evaluation, the suspect medical device was changed from architect total b-hcg reagent kit, list number 07k78-25, and manufacturing site in section d of this report, longford to architect i2000sr instrument list number 03m74-97, and manufacturing site of new suspect device, irving.Mdr number 3016438761-2024-00363 has been submitted and all further information will be documented under that mdr number.
Event or Problem Description
The customer observed false negative architect total b-hcg results that were inconsistent with clinical picture on (b)(6) 2024.The customer retested on (b)(6) 2024 and the results were positive, which was aligned with the patient¿s clinical observation.No 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): ABBOTT IRELAND DIAGNOSTICS DIVISION; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer (Section G): ABBOTT IRELAND DIAGNOSTICS DIVISION; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 19221758
• Report Number: 3005094123-2024-00220
• Device Sequence Number: 7016852
• Product Code: DHA
• UDI-Device Identifier: 00380740014964
• UDI-Public: (01)00380740014964(17)241102(10)58183UD00
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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): 06/17/2024

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 Catalogue Number: 07K78-25
• Device Lot Number: 58183UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/25/2024
• Supplement Date Received by Manufacturer: 06/05/2024
• Initial Report FDA Received Date: 05/01/2024
• Supplement Report FDA Received Date: 06/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 I2SR REFURB-SEKAT, 03M74-97, (B)(6); ARC I2SR REFURB-SEKAT, 03M74-97, (B)(6)
• Patient Sex: Unknown