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

Catalog Number 07K76-74

Device Problem Low Test Results (2458)

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

Event Date 02/06/2024

Event Type  malfunction  

Event Description

The customer observed falsely depressed architect prolactin results on a 16 year-old female patient.The result was not reported out.The patient was repeated on the same instrument multiple times with higher results.The following data was provided: initial result = 3556.9 miu/ml repeat results = 247.65 miu/ml the sample was centrifuged again and repeated with results of 3731.33 and 3495.92 miu/ml reference range: 108.78-557.13 miu/ml 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

The complaint investigation for falsely depressed architect prolactin results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, device history record review, in-house testing, and labeling review of architect prolactin reagent, lot 53047ud01.Return testing was not completed as returns were not available.The ticket search determined that there is as expected complaint activity for the likely cause lot.A review of tracking and trending data did not identify any related trends for the product for the issue.Return testing was not completed as returns were not available.Device history record review did not identify any non-conformances or deviations with the complaint lot and complaint issue.Accuracy testing was completed using panels which mimic patient samples using an in-house retained kit stored at the recommended storage condition.All specifications were met indicating that the lot is performing acceptably.A review of labeling was performed and found to and sufficiently address the customer's issue.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.There was no issue with reagent performance identified.A review of the product labeling concluded that the issue is sufficiently addressed.Based on this investigation, no systemic issue or deficiency was identified for the architect prolactin reagent lot 53047ud01.

Event Description

The customer observed falsely depressed architect prolactin results on a 16 year-old female patient.The result was not reported out.The patient was repeated on the same instrument multiple times with higher results.The following data was provided: initial result = 3556.9 miu/ml repeat results = 247.65 miu/ml the sample was centrifuged again and repeated with results of 3731.33 and 3495.92 miu/ml reference range: 108.78-557.13 miu/ml no impact to patient management was reported.

• 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: 18828287
• MDR Text Key: 337301353
• Report Number: 3005094123-2024-00090
• 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
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07K76-74
• Device Lot Number: 53047UD01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2023
• 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, ISR61640; ARC I2000SR INST, 03M74-02, ISR61640
• Patient Age: 16 YR
• Patient Sex: Female