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	03/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information: no specific patient 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 obtained a false positive architect total b-hcg result.On (b)(6) 2020 sample id (b)(6) generated a positive result of 3413.13 iu/l.The sample was retested on (b)(6) 2020 and generated a negative result of <1.2 iu/l.No impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation for false positive results for one patient 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, field data review and inhouse testing of retained kits with the complaint lot number.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.Inhouse testing of a retained kit of reagent lot 03333ui00 determined that the lot is performing acceptably.The overall performance of the architect total b-hcg reagents in the field was reviewed using data gathered from customers worldwide and suggested that the performance of the lot is acceptable.Based on our investigation, we have determined that there is no general issue or deficiency of the architect total b-hcg reagent lot 03333ui00.

• 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: 10399342
• Report Number: 3005094123-2020-00172
• Device Sequence Number: 2948681
• 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
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2020

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: 04/16/2020
• Device Model Number: 7K78-30
• Device Catalogue Number: 07K78-30
• Device Lot Number: 03333UI00
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/17/2020
• Supplement Date Received by Manufacturer: 09/10/2020
• Initial Report FDA Received Date: 08/12/2020
• Supplement Report FDA Received Date: 09/14/2020
• 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)(6) ; SERIAL (B)(6)