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

Catalog Number 07K78-74

Device Problem False Positive Result (1227)

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

Event Date 07/11/2020

Event Type  malfunction  

Manufacturer Narrative

Patient information: no further patient information was provided by the customer.An evaluation is in process.A follow up report will be submitted when the evaluation is complete.

Event Description

The customer reported a false positive architect b-hcg assay results for a (b)(6) female undergoing an abortion procedure.The customer provided: on (b)(6) 2020 result = 38.07 miu/ml (pre procedure); on (b)(6) 2020 result = 5.70 miu/ml (post procedure); on (b)(6) 2020 result = 3.48 miu/ml; on (b)(6) 2020 result = 206.85 miu/ml; on (b)(6) 2020 result = 1.87 miu/ml.The (b)(6) 2020 result was from the same tube draw as (b)(6) 2020 result (ref range: 0 to 5.0 miu/ml).The (b)(6) 220 result of 206.85miu/ml was released, and thus questioned by physician.The (b)(6) 2020 result, 1.87miu/ml, was in line with clinical expectations.There was no impact to patient management reported.

Manufacturer Narrative

The complaint investigation 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 in-house testing of retained kits with the complaint lot number.Trending review determined no trends for the product.Device history record review did not identify any non-conformances or deviations with the likely cause lot.In-house testing determined that the accuracy performance is not negatively impacted.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 of the lot is acceptable.Return testing was not completed as returns were not available.Based on our investigation, we have determined that there is no a systemic issue and/or product deficiency with architect total b-hcg reagent lot 08042ui01.

• 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: 10407186
• MDR Text Key: 203108210
• Report Number: 3005094123-2020-00174
• Device Sequence Number: 1
• Product Code: DHA
• Combination Product (y/n): N
• 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: 11/06/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 09/20/2020
• Device Catalogue Number: 07K78-74
• Device Lot Number: 08042UI01
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/25/2020
• Initial Date FDA Received: 08/14/2020
• Supplement Dates Manufacturer Received: 11/06/2020
• Supplement Dates FDA Received: 11/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2000SR INST, 03M74-02, (B)(6) ; ARCHITECT I2000SR ANALYZER; LN 03M74-02, SN (B)(6)
• Patient Age: 39 YR