MAUDE Adverse Event Report: A.I.D.D LONGFORD ARCHITECT TOTAL B-HCG

Model Number	7K78-30
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/24/2020
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.Patient identifier complete entry = (b)(6) and (b)(6).All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed a falsely elevated architect total b-hcg result for one patient.The following data was provided (less than 5.00 miu/ml is negative, greater than equal to 25.00 miu/ml is positive): sample id (b)(6) initial result was 269.89 miu/ml.The result was questioned by the physician, so the sample was repeated, the result was less than 1.2 miu/ml.The patient was redrawn, sample id (b)(6), and the result was less than 1.2 miu/ml.There was no impact to patient management reported.
Additional Manufacturer Narrative
Section d4 catalog# was changed from 07k78-30 to 07k78-25.
Additional Manufacturer Narrative
The complaint investigation for a falsely elevated architect total b-hcg result 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 field data review for the complaint lot.Trending review determined no related trend for the product.Manufacturing documentation for the likely cause lot was reviewed and did not identify any issues.Device history record review on lot number 10179ui00 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 abbottlink from customers worldwide and suggested that the performance is acceptable.No systemic issue or deficiency of the architect total b-hcg assay was identified.Based on the information provided and abbott diagnostics¿ complaint investigation, no systemic issue or deficiency of architect total b-hcg, lot number 10179ui00, was identified.

• Brand Name: ARCHITECT TOTAL B-HCG
• Common Device Name: B-HCG
• Manufacturer (Section D): A.I.D.D LONGFORD; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• MDR Report Key: 10512245
• Report Number: 3005094123-2020-00202
• Device Sequence Number: 3749665
• 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
• 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): 11/24/2020

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: 12/11/2020
• Device Model Number: 7K78-30
• Device Catalogue Number: 07K78-25
• Device Lot Number: 10179UI00
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/24/2020
• Supplement Date Received by Manufacturer: 09/11/2020; 11/23/2020
• Initial Report FDA Received Date: 09/09/2020
• Supplement Report FDA Received Date: 09/22/2020; 11/24/2020
• 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)(6) ; ARCHITECT I2000SR PROCESSING MODULE,; ARCHITECT I2000SR PROCESSING MODULE,; LIST# 03M74-02, SERIAL# (B)(6) ; LIST# 03M74-02, SERIAL# (B)(6)