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

Model Number 7K78-25

Device Problem False Positive Result (1227)

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

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: initial = 38.8miu/ml (>/=25.00miu/ml = positive) / the sample was retested with the roche platform and the result was <1.The customer retested the sample after receiving feedback from a clinical physician; the result was 36.9miu/ml.There was no reported impact to patient management.The patient is diagnosed with rheumatoid arthritis and their rf results were significantly abnormal.

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, labeling review, device history record review, field data review and inhouse testing of retained kits with the complaint lot number.Trending review determined no trends for the product.Return testing was not completed as returns were not available.Accuracy testing was performed with a retained kit of lot 06106ui00 and all specifications were met indicating that the lot is performing acceptably.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.Device history record review did not identify any non-conformances or deviations with the lot.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the architect total b-hcg reagent, lot 06106ui00.

• 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: 10155077
• MDR Text Key: 226764730
• Report Number: 3005094123-2020-00123
• Device Sequence Number: 1
• Product Code: DHA
• UDI-Device Identifier: 00380740014964
• UDI-Public: 00380740014964
• 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: 07/08/2020

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: 07/16/2020
• Device Model Number: 7K78-25
• Device Catalogue Number: 07K78-25
• Device Lot Number: 06106UI00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/24/2020
• Initial Date FDA Received: 06/15/2020
• Supplement Dates Manufacturer Received: 07/01/2020
• Supplement Dates FDA Received: 07/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR ANALYZER, LN 03M74-02,; ARCHITECT I2000SR ANALYZER, LN 03M74-02,; SERIAL # (B)(4); SERIAL # (B)(4)
• Patient Age: 42 YR