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

Catalog Number	07K78-30
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a1 - patient identifier: complete sid is (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed false negative architect total b-hcg result on a patient who is being tested two weeks after the ivf procedure.The architect total b-hcg result was <1.2 miu/ml (negative).The patient was expected to have a result of about 200 miu/ml (positive).The customer stated the patient¿s hormonal support was discontinued.It was noted that a frozen pregnancy was later established.Additional information regarding the incident was requested; however, to date, it has not been provided and/or received.On 11dec2023, the customer provided clarification regarding the words ¿frozen pregnancy¿.The customer stated it meant an early unintended end to the pregnancy.The patient¿s sid was (b)(6).No further impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation for false negative architect total b-hcg result included a review of data and information provided by the customer, search for similar complaints, ticket trending review, device history record review, and labeling review.In-house testing of retained reagent kit was also completed.Return testing was not completed as returns were not available.The data and information provided by the customer were reviewed and support the complaint issue.A ticket search by lot indicates the reagent lot is performing as expected for this product.A review of the complaint trending report did not identify any trends for the issue for the product.A review of the device history record did not identify any non-conformances or deviations with lot 45625ud00 and complaint issue.An accuracy testing was completed using panels which mimic patient samples using an in-house retained kit stored at the recommended storage condition.All specifications were met indicating that the lot is performing acceptably.A review of labeling was performed and found to sufficiently address the customer's issue.Based on the review of this issue, the customer did not follow product labeling as required, therefore this event is deemed incorrect use.Based on this investigation, no systemic issue or deficiency was identified for the architect total b-hcg reagent lot 45625ud00.
Event or Problem Description
The customer observed false negative architect total b-hcg result on a patient who is being tested two weeks after the ivf procedure.The architect total b-hcg result was <1.2 miu/ml (negative).The patient was expected to have a result of about 200 miu/ml (positive).The customer stated the patient¿s hormonal support was discontinued.It was noted that a frozen pregnancy was later established.Additional information regarding the incident was requested; however, to date, it has not been provided and/or received.On (b)(6) 2023, the customer provided clarification regarding the words ¿frozen pregnancy¿.The customer stated it meant an early unintended end to the pregnancy.The patient¿s sid was (b)(6).No further 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: 18317922
• Report Number: 3005094123-2023-00369
• Device Sequence Number: 14981201
• Product Code: DHA
• UDI-Device Identifier: 00380740014971
• UDI-Public: 00380740014971
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• 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,Followup
• Report Date (Section B): 01/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/03/2024
• 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): Initial
• Initial Date Received by Manufacturer: 11/23/2023
• Supplement Date Received by Manufacturer: 12/22/2023
• Initial Report FDA Received Date: 12/13/2023
• Supplement Report FDA Received Date: 01/08/2024
• 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 I2SR REFURB-SEKAT, 03M74-97, ISR02590; ARC I2SR REFURB-SEKAT, 03M74-97, ISR02590
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female