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

Model Number 7K78-30

Device Problem False Positive Result (1227)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/10/2020

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.There was no additional patient information provided by the customer.

Event Description

The customer reported a false positive architect b-hcg result on one patient.The results provided were: (b)(6) initial = 501.56miu/ml (>/=25.00miu/ml = positive) / retest = <1.2miu/ml (<5.00miu/ml =negative).There was no reported impact to patient management.

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 for the complaint lot.Return testing was not completed as returns were not available.Trending review determined no trends for the product.Device history record review did not identify any non-conformances or deviations with lot 06335ui00.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.Based on the investigation no product deficiency was identified for the architect total b-hcg reagent lot 06335ui00.

• Brand Name: ARCHITECT TOTAL B-HCG
• Type of Device: B-HCG
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION LONGFORD; lisnamuck; co. longford; longford NA ; EI NA
• MDR Report Key: 10200392
• MDR Text Key: 222187971
• Report Number: 3005094123-2020-00135
• Device Sequence Number: 1
• Product Code: DHA
• UDI-Device Identifier: 00380740014971
• UDI-Public: 00380740014971
• Combination Product (y/n): N
• PMA/PMN Number: K983424
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/21/2020
• Device Model Number: 7K78-30
• Device Catalogue Number: 07K78-30
• Device Lot Number: 06335UI00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR ANALYZER, LN 03M74-01,; ARCHITECT I2000SR ANALYZER, LN 03M74-01,; SERIAL # (B)(6); SERIAL # (B)(6)