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	02/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.No patient information is available.Facility name is truncated.Full facility name is (b)(6).
Event or Problem Description
The customer generated a (b)(6) architect total b-hcg results for one patient.The following information was provided: initial result (b)(6).No impact to patient management was reported.
Additional Manufacturer Narrative
H6 health effect impact code: f26.Component code: g01003.D8 was this device serviced by a third party? unknown.A review of tickets was performed for reagent lot number 15730ui02.The ticket search determined that there is elevated complaint activity for the reagent lot.A review of tracking and trending did not identify any trends for the complaint issue.Return testing was not completed as returns were not available.A retained reagent kit of lot number 15730ui02 was tested.All validity and acceptance criteria were met during completion of the protocol, demonstrating that the lot is performing acceptably.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.A review of labeling concluded that the issue is sufficiently addressed.Based on the investigation no systemic issue or deficiency of the architect total -hcg reagent lot 15730ui02 was identified.
Event or Problem Description
The customer generated a false positive architect total b-hcg results for one patient.The following information was provided: initial result 13595.59 miu/ml (positive), repeat in duplicate <1.2 miu/ml (negative) no impact to patient management was reported.
Additional Manufacturer Narrative
This follow up is submitted to populate fields d8 and/or h6 with data that had previously been provided in field h10.There is no change to the content of the data.

• 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: 11356674
• Report Number: 3005094123-2021-00028
• Device Sequence Number: 14472684
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/22/2021

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: 06/10/2021
• Device Model Number: 7K78-30
• Device Catalogue Number: 07K78-30
• Device Lot Number: 15730UI02
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/06/2021
• Supplement Date Received by Manufacturer: 03/02/2021; 06/20/2021
• Initial Report FDA Received Date: 02/21/2021
• Supplement Report FDA Received Date: 03/26/2021; 06/22/2021
• 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, ISR62794; ARC I2000SR INST, 03M74-02, ISR62794; ARC I2000SR INST, 03M74-02, ISR62794