MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION LONGFORD ARCHITECT TOTAL B-HCG

Model Number	7K78-30
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information: no further information was provided.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported a false positive architect b-hcg result that was questioned by the doctor who stated that the patient was a non-pregnant (b)(6) year-old female.The results provided were: on (b)(6) 2020 = positive (100.10 miu/ml) (reference range >/= to 25.00 miu/ml = positive), repeated on the same sample on (b)(6) 2020 = positive (119.19 miu/ml).The customer further retested the sample across three architect analyzers generating results ranging from 99.37 to 122.80 miu/ml.No impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation for false positive results when tested with the architect total b-hcg assay included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labelling review, device history record review and field data review.Review of trending data for the architect total b-hcg assay identified no trends.Device history record review associated with the reagent lot did not identify any non-conformances or deviations.The overall performance of the architect total bhcg reagents in the field was reviewed using data gathered from customers worldwide and suggested that the performance of reagent lot 10402ui00 is acceptable.Based on our investigation, no systemic issue or deficiency of the architect total b-hcg reagent lot 10402ui00 was identified.

• Brand Name: ARCHITECT TOTAL B-HCG
• Common Device Name: B-HCG
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION LONGFORD; lisnamuck; co. longford; longford NA ; EI NA
• MDR Report Key: 10298815
• Report Number: 3005094123-2020-00155
• Device Sequence Number: 2698014
• Product Code: DHA
• UDI-Device Identifier: 00380740014971
• UDI-Public: 00380740014971
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Report Date (Section B): 09/10/2020

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: 11/06/2020
• Device Model Number: 7K78-30
• Device Catalogue Number: 07K78-30
• Device Lot Number: 10402UI00
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/30/2020
• Supplement Date Received by Manufacturer: 09/10/2020
• Initial Report FDA Received Date: 07/20/2020
• Supplement Report FDA Received Date: 09/10/2020
• 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: ARCHITECT I2000SR, LIST 03M74-02,; ARCHITECT I2000SR, LIST 03M74-02,; SERIAL (B)(4); SERIAL (B)(4)
• Patient Age: 51 YR