MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ARCHITECT PROLACTIN REAGENT KIT; RADIOIMMUNOASSAY, PROLACTIN (LACTOGEN)

Catalog Number 07K76-78

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/03/2023

Event Type  malfunction  

Event Description

The customer observed falsely depressed architect prolactin results for one patient.The prolactin result was 16.81 miu/l and after calibration the retest result was 110.26 miu/l, and the result of another i2000 was 109.75 miu/l.No impact to patient management was reported.

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Manufacturer Narrative

Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.The ticket search by lot indicates that the reagent lot performs as expected for this product.Return testing was not performed as returns were not available.Device history record review was performed, which did not show any potential non-conformances, deviations, or non-conformances related to the issue under review.Trending review did not identify any trends.Historical performance was evaluated using worldwide field data.Review of the lots show that all median values are within 2sd of the mean indicating that the lots are comparable and performing acceptably in the field.Statistical process control (spc) analysis was performed for the architect prolactin assay.No unusual variation was observed.Labeling review concludes that the issue is adequately addressed.Based on the investigation, no systemic issue or deficiency of the architect prolactin assay was identified.Corrected information found in section d4 catalog number and lot number.

Manufacturer Narrative

Corrected data found in section d4 lot number and list number.

• Brand Name: ARCHITECT PROLACTIN REAGENT KIT
• Type of Device: RADIOIMMUNOASSAY, PROLACTIN (LACTOGEN)
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer (Section G): ABBOTT IRELAND DIAGNOSTICS DIVISION; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 18153021
• MDR Text Key: 328745794
• Report Number: 3005094123-2023-00321
• Device Sequence Number: 1
• Product Code: CFT
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/20/2024
• Device Catalogue Number: 07K76-78
• Device Lot Number: 48500UD03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2000SR INST, 03M74-02, (B)(6); ARC I2000SR INST, 03M74-02, (B)(6); ARC I2000SR INST, 03M74-02, (B)(6)