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

Catalog Number	07K76-35
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/11/2018
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.Patient information: no further patient information was provided.
Event or Problem Description
The customer reported a falsely depressed architect prolactin result for a (b)(6) female.Sample id (b)(6) generated a result of 24.82 ng/ml on a new lot and on the previous lot 44.83 ng/ml.No adverse impact to patient management was reported.
Additional Manufacturer Narrative
Review of complaint activity determined that there is normal complaint activity for likely cause lot 91424ui00.Tracking and trending report review for the architect prolactin assay determined that there are no related adverse or non-statistical trends.Statistical process control (spc) analysis was performed for the architect prolactin assay.No unusual variation was observed.Using worldwide field data, the historical performance of reagent lot 91424ui00 was evaluated and compared to the performance of all architect prolactin reagent lots in the field.This evaluation indicated that the patient median result for lot 91424ui00 was within 1 standard deviation of the overall median for the assay.Therefore, no unusual reagent lot performance was identified.Testing of an in-house panel which mimic patient samples was completed using retained kits of the likely cause lot.All specifications were met indicating that lot 91424ui00 is performing acceptably.Manufacturing documentation for the likely cause lot did not identify any issues associated with the complaint issue.Additionally, labeling was reviewed and sufficiently addresses the customer's issue.No systemic issue or deficiency of the architect prolactin assay was identified.

• 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: 8184636
• Report Number: 3005094123-2018-00259
• Device Sequence Number: 13828428
• 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): 03/27/2019

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: 08/21/2019
• Device Catalogue Number: 07K76-35
• Device Lot Number: 91424UI00
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/11/2018
• Supplement Date Received by Manufacturer: 03/27/2019
• Initial Report FDA Received Date: 12/20/2018
• Supplement Report FDA Received Date: 03/27/2019
• 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, LIST 03M75-58; ARCHITECT I2000SR, LIST 03M75-58; SERIAL ISR06753; SERIAL ISR06753
• Patient Age: 35 YR