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 06/12/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluation is in process.A follow-up will be submitted once the evaluation is complete.

Event Description

The customer stated that a false positive architect total bhcg result of 494.04 miu/ml was generated for a patient sample that retested negative at <1.2 miu/ml.The patient is a (b)(6) year old female without childbearing potential.No adverse impact to patient management was reported.

Manufacturer Narrative

The complaint investigation for a false positive result 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 and field data review for the complaint lot.Trending review determined no adverse trend for the product.Device history record review did not identify any non-conformances or deviations with the likely cause lot.In house testing of panels which mimic patient samples was completed using retained samples of the complaint lot.All specifications were met indicating that the lot is performing acceptably.World wide data from abbottlink was reviewed and determined that patient median result for the lot is comparable with other lots in the field.Based on our investigation, we have determined that there is no general issue with the architect total b-hcg reagent lot identified in the complaint.

• 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: 10186893
• MDR Text Key: 226764803
• Report Number: 3005094123-2020-00133
• 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: 08/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/20/2020
• Device Model Number: 7K78-30
• Device Catalogue Number: 07K78-30
• Device Lot Number: 04405UI00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR ANALYZER, LIST 03M74-02; ARCHITECT I2000SR ANALYZER, LIST 03M74-02,; SERIAL NUMBER (B)(4); SERIAL NUMBER (B)(4)
• Patient Age: 50 YR