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

Model Number 7K78-25

Device Problem False Negative Result (1225)

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

Event Type  malfunction  

Manufacturer Narrative

All available patient information has been included.No additional patient details are available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer reported a false negative b-hcg result when processing on the architect i2000sr.The initial and retest results were <1.2 miu/ml.Additional testing with colloidal gold method was positive.No impact to patient management was reported.

Manufacturer Narrative

An investigation was performed for the customer issue and included a review of the complaint text, a search for similar complaints, a review of trending data, a review of product quality history, and a review of product labeling.The ticket searches determined that there was elevated complaint activity for the lot under review, however this is the only ticket related to false depressed/ false negative results.A review of trending data did not identify any trends.A test protocol was executed using retained samples of likely cause lot.All validity and acceptance criteria were met, indicating the lot is performing acceptably.A review of the product quality history for the lot number using worldwide data did not identify any issues.Labeling was reviewed and found to be adequate.No systemic issue was identified.Based on all available information and abbott diagnostics' complaint investigation a product deficiency was not 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: 9501383
• MDR Text Key: 219779249
• Report Number: 3005094123-2019-00387
• 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: 03/06/2020

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: 03/07/2020
• Device Model Number: 7K78-25
• Device Catalogue Number: 07K78-25
• Device Lot Number: 02376UI00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/08/2019
• Initial Date FDA Received: 12/20/2019
• Supplement Dates Manufacturer Received: 02/20/2020
• Supplement Dates FDA Received: 03/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR ANALYZER; ARCHITECT I2000SR, LIST 03M74-02; LIST 03M74-02 SERIAL (B)(4); SERIAL (B)(4)