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	06/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No specific patient information was provided.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer obtained falsely elevated architect prolactin results.Sample 1 generated results of 49 and 49.89 ng/ml on the architect and at an alternate lab (method unknown) 26.46 ng/ml.No impact to patient management was reported.
Additional Manufacturer Narrative
The customer provided two additional discrepant sample results which were included in section b5.No specific patient information was provided.The complaint investigation included a search for similar complaints, in-house retained kit testing and review of complaint text, trending data, labeling, and device history records.Return testing was not completed as returns were not available.Review of trending reports identified no trends for the complaint issue.Labelling was reviewed and found to adequately address the complaint issue.Device history record review did not identify any non-conformances or deviations for the complaint lot.In house testing of panels which mimic patient samples was completed using retained kits of the complaint lot.All specifications were met indicating that the lot is performing acceptably.Based on the investigation, no systemic issue or deficiency of the architect prolactin lot was identified.
Event or Problem Description
On (b)(6) 2021 the customer provided two additional falsely elevated architect prolactin results: sample 3: architect 168.67, 158.94 and 163.63 ng/ml; retest at two alternate labs (chemiluminescence technique) 26.16 and 23 ng/ml sample 4: architect 200 and 237.91 ng/ml; retest at an alternate lab (chemiluminescence technique) 131.68 ng/ml no impact to patient management was reported.

• 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
• MDR Report Key: 12129714
• Report Number: 3005094123-2021-00129
• Device Sequence Number: 14325259
• Product Code: CFT
• UDI-Device Identifier: 00380740014865
• UDI-Public: 00380740014865
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 08/13/2021

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 Expiration Date: 10/05/2021
• Device Model Number: 7K76-25
• Device Catalogue Number: 07K76-25
• Device Lot Number: 21333UI00
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/16/2021
• Supplement Date Received by Manufacturer: 07/23/2021
• Initial Report FDA Received Date: 07/07/2021
• Supplement Report FDA Received Date: 08/13/2021
• 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 I2SR REFURB-BRAZIL, 03M74-56, ISR06899; ARC I2SR REFURB-BRAZIL, 03M74-56, ISR06899; ARC I2SR REFURB-BRAZIL, 03M74-56, (B)(4)