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

Model Number 7K78-25

Device Problem High Test Results (2457)

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

Event Date 03/02/2020

Event Type  malfunction  

Manufacturer Narrative

Complete information for section a: patient sid; (b)(6) all available patient information was included, no additional patient information was available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The account generated false positive architect bhcg of 30.74 and 32 miu/ml on a sample id (b)(6) that repeated negative <1.20 miu/ml.No impact to patient management was reported.

Manufacturer Narrative

The ticket search determined normal complaint activity for the complaint lot.Complaint trending report review determined that there is no adverse trend for the product.A review of the product labeling concluded that the issue is sufficiently addressed.No customer returns were available for evaluation.Historical performance in the field of reagents lots using worldwide data was evaluated.The patient median result for lot 06106ui00 is comparable with all other lots in the field and confirms no systemic issue for the product lot.A review of the product quality history for the lot number did not identify issues associated with the customers observation.No product deficiency was identified.

• 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: 9824278
• MDR Text Key: 221029056
• Report Number: 3005094123-2020-00074
• 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: 04/21/2020

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: 03/02/2020
• Initial Date FDA Received: 03/12/2020
• Supplement Dates Manufacturer Received: 03/24/2020
• Supplement Dates FDA Received: 04/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR ANALYZER; ARCHITECT I2000SR ANALYZER; LIST 03M74-02 SN (B)(6) ; LIST 03M74-02 SN (B)(6)