MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION LONGFORD ARCHITECT PROLACTIN

Model Number 7K76-25

Device Problem Low Test Results (2458)

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

Event Date 06/17/2020

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 observed a falsely depressed architect prolactin result for one patient.The following data was provided: (b)(6) 2020, sid (b)(6), initial result = 450 miu/l, repeat = 803 miu/l.The physician questioned the initial result since the patient had prolactin result of 800 miu/l at another laboratory.No impact to patient management was reported.

Manufacturer Narrative

The complaint investigation for the observed falsely depressed result included a search for similar complaints, and the review of complaint text, trending data, labeling, and device history records.Return testing was not completed as returns were not available.In-house accuracy testing of reagent lot 07137ui00 was completed.Trending review identify any trends for the complaint issue.In house accuracy 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.A review of field data for lot 07137ui00 determined the patient median result for the lot is comparable with other lots in the field.Device history record review on lot 07137ui00 did not show any potential non-conformances, or deviations.Labeling was reviewed and found to adequately address the issue under review.Based on the investigation, no systemic issue or deficiency of the architect prolactin lot number 07137ui00 was identified.

• Brand Name: ARCHITECT PROLACTIN
• Type of Device: PROLACTIN
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION LONGFORD; lisnamuck; co. longford; longford NA ; EI NA
• MDR Report Key: 10288795
• MDR Text Key: 201870273
• Report Number: 3005094123-2020-00151
• Device Sequence Number: 1
• Product Code: CFT
• UDI-Device Identifier: 00380740014865
• UDI-Public: 00380740014865
• 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: 08/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/23/2020
• Device Model Number: 7K76-25
• Device Catalogue Number: 07K76-25
• Device Lot Number: 07137UI00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR PROCESSING MODULE; ARCHITECT I2000SR PROCESSING MODULE; LIST 03M74-02, SERIAL (B)(6); LIST 03M74-02, SERIAL (B)(6)