MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION 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	04/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1 patient identifier: complete sample id's are (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed false negative architect total b-hcg and provided the following data on two patients: patient 1 was 29 years old.Sample id:(b)(6).On (b)(6) 2023 b-hcg result was negative (no numerical result provided).The patient had an ultrasound the same day which confirmed the pregnancy, which was reported to show fetal location in the uterine cavity, the correct oval shape, and mean internal diameter of the ovum was 0.9 cm.Patient 2 was 25 years old.Sample id: (b)(6).On (b)(6) 2023 result was <1.2 miu/ml.The sample was repeated on (b)(6) 2023 and the result was <1.2 miu/ml.On (b)(6) 2023 a new sample was obtained (sample id (b)(6)), which generated a result of <1.2 miu/ml.A rapid urine test generated a positive result.It was reported that the sample was retested on another instrument in the lab and generated a result of <1.2 miu/ml.There was no reported impact to patient management.
Event or Problem Description
The customer observed false negative architect total b-hcg and provided the following data on two patients: patient 1 was 29 years old.Sample id: (b)(6).On 28 apr 2023 b-hcg result was negative (no numerical result provided).The patient had an ultrasound the same day which confirmed the pregnancy, which was reported to show fetal location in the uterine cavity, the correct oval shape, and mean internal diameter of the ovum was 0.9 cm.Patient 2 was 25 years old.Sample id: (b)(6).On 29 may 2023 result was <1.2 miu/ml.The sample was repeated on 31 may 2023 and the result was <1.2 miu/ml.On 01 june 2023 a new sample was obtained (sample id (b)(6)), which generated a result of <1.2 miu/ml.A rapid urine test generated a positive result.It was reported that the sample was retested on another instrument in the lab and generated a result of <1.2 miu/ml.There was no reported impact to patient management.
Additional Manufacturer Narrative
The complaint investigation regarding false non-reactive architect total ss-hcg reagent lot number 45625ud00 included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, and in house testing.Return testing was not completed as returns were not available.The ticket search by lot indicates that the reagent lot performs as expected for this product.Ticket and trending review did not identify any trends regarding commonalities for lot number and the issue.Device history record review did not identify any nonconformance or deviation associated with lot 45625ud00 and the complaint issue.In house testing was conducted using panels which mimic patient samples and determined that specifications were met indicating that the lot is performing acceptably.A labeling review determined product labeling provides adequate information regarding the customer issue.Based on the investigation, no systemic issue or deficiency with the architect total ss-hcg reagent lot number 45625ud00 was identified.

• 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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 17183311
• Report Number: 3005094123-2023-00155
• Device Sequence Number: 6333664
• Product Code: DHA
• UDI-Device Identifier: 00380740014971
• UDI-Public: 00380740014971
• Combination Product (Y/N): N
• Initial Reporter Country: KZ
• 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): 08/01/2023

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: 01/03/2024
• Device Model Number: 7K78-30
• Device Catalogue Number: 07K78-30
• Device Lot Number: 45625UD00
• 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: 06/05/2023
• Supplement Date Received by Manufacturer: 07/18/2023
• Initial Report FDA Received Date: 06/22/2023
• Supplement Report FDA Received Date: 08/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2023
• 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, ISR63209; ARC I2000SR INST, 03M74-02, ISR63209
• Patient Sex: Female