MAUDE Adverse Event Report: A.I.D.D LONGFORD ARCHITECT PROLACTIN

Model Number	7K76-35
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed falsely elevated architect prolactin result for 1 sample when compared to beckman analyzer.The following data was provided: initial result = 857.65 miu/l, repeat = 785.61 miu/l (reference range = 108.78 to 557.13 miu/l), beckman = 278.31 uiu/ml (reference range = 70.81 to 566.46) no impact to patient management was reported.
Additional Manufacturer Narrative
Further investigation into the customer issue did not identify any trends for the architect prolactin reagent, lot 05259ui01.Testing was performed using an in-house retained kit and all specifications were met indicating the lot is preforming acceptably.No return patient sample was available.Manufacturing documentation was reviewed, and no issues were identified.Additionally, labeling was reviewed and adequately addresses the customer issue.Based on the investigation, no systemic issue or product deficiency was identified for the architect prolactin reagent.

• Brand Name: ARCHITECT PROLACTIN
• Common Device Name: PROLACTIN
• Manufacturer (Section D): A.I.D.D LONGFORD; lisnamuck; co. longford; longford NA ; EI NA
• MDR Report Key: 9334583
• Report Number: 3005094123-2019-00321
• Device Sequence Number: 19394181
• Product Code: CFT
• UDI-Device Identifier: 00380740105990
• UDI-Public: 00380740105990
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2020

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: 06/07/2020
• Device Model Number: 7K76-35
• Device Catalogue Number: 07K76-35
• Device Lot Number: 05259UI01
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/05/2019
• Supplement Date Received by Manufacturer: 01/21/2020
• Initial Report FDA Received Date: 11/18/2019
• Supplement Report FDA Received Date: 01/22/2020
• 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: ARCHITECT I2000SR PROCESSING MODULE; ARCHITECT I2000SR PROCESSING MODULE, LIST 03M74-02; LIST 03M74-02, SERIAL (B)(4); SERIAL (B)(4)