MAUDE Adverse Event Report: A.I.D.D LONGFORD ARCHITECT PROLACTIN REAGENT KIT; RADIOIMMUNOASSAY, PROLACTIN (LACTOGEN)

Model Number	7K76-25
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The customer questioned architect prolactin results for one patient.The customer noted the patient was tested 4-5 times from 2020- 2022 with prolactin ranging from 70-100 ng/l and sids (b)(6).At one point the customer reported result of 96.2 out of the lab- while total prolactin on the same sample from another lab was 31ng/l (external lab has a similar ref range) with a macroprolactin result of 0.421 (positive macroprolactin stated at >0.4).The patient is asymptomatic but has been subjected to pituitary imaging (mri) with contrast due to the results, which didn¿t show any anomalies, and has been followed up on numerous occasions by the endocrine clinic.The patient did not suffer any adverse effects from the mri and was noted as having no symptoms of hyperprolactinemia at all.The high prolactin was picked up incidentally on labs ordered by primary care several years ago.The patient was noted to have some features of pcos, and per the physician the mildly elevated prolactin from icl would be much more in keeping with that presentation rather than the values between 70-100 ug/l.No impact to patient management was reported.
Additional Manufacturer Narrative
Multiple sids were provided for the same patient.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, and field data review.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.Ticket and trending review did not identify any trends.Device history review did not identify any non-conformances or deviations with the complaint list number.The overall performance of the architect prolactin reagents in the field was reviewed using data gathered from customers worldwide.The median population result for all lots falls within 2sd indicating the lot is performing acceptably.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the architect prolactin reagent was identified.Corrected information in section d3-email and g1-mfg site email.

• Brand Name: ARCHITECT PROLACTIN REAGENT KIT
• Common Device Name: RADIOIMMUNOASSAY, PROLACTIN (LACTOGEN)
• Manufacturer (Section D): A.I.D.D LONGFORD; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer (Section G): A.I.D.D LONGFORD; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 14282371
• Report Number: 3005094123-2022-00091
• Device Sequence Number: 14739964
• Product Code: CFT
• UDI-Device Identifier: 00380740014865
• UDI-Public: 00380740014865
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2022

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
• Operator of Device: Health Professional
• Device Model Number: 7K76-25
• Device Catalogue Number: 07K76-25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/20/2022
• Supplement Date Received by Manufacturer: 06/24/2022
• Initial Report FDA Received Date: 05/04/2022
• Supplement Report FDA Received Date: 06/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARC I2000SR INST, 03M74-02, ISR52296.; ARC I2000SR INST, 03M74-02, ISR52296.
• Patient Sex: Unknown