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

Catalog Number	07K76-35
Medical Device Problem Code	Low Test Results (2458)
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 depressed results while using architect prolactin reagents.The following data was provided: sid (b)(6) (using lot 91424ui00) initial 25.33 ng/ml, repeat 24.44 ng/ml.Test using previous lot (89425ui00) was higher, sid (b)(6) 40.48 ng/ml.No impact to patient management was reported.
Additional Manufacturer Narrative
Investigation of the customer issue included a review of compliant text, a search for similar complaints, a review of field data, a review of instrument logs, a review of historical data, a review of product quality history, and statistical process control analysis.No adverse trend, non-statistical trends, non-conformities, potential non-conformities, or deviations were identified for the customer's issue.Labeling was reviewed and found to be adequate.Field data did not identify any issue related to overall performance and found no systemic issues.Field data indicated that median patient result for the likely cause lot is within established limits.Review of the instrument logs did not identify any sample integrity issues.Testing was performed using in-house retained kits and the testing met all specifications.Review of statistical process control analysis did not identify any issues for the reporting lot.Based on all available information no product deficiency 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: 8200511
• Report Number: 3005094123-2018-00280
• Device Sequence Number: 1699142
• 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): 03/21/2019

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
• Initial Date Received by Manufacturer: 12/04/2018
• Supplement Date Received by Manufacturer: 03/06/2019
• Initial Report FDA Received Date: 12/27/2018
• Supplement Report FDA Received Date: 03/21/2019
• 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: ARCH I2000SR LN 03M74-02.; ARCHITECT I2000SR LN 03M74-02.; ARCHITECT PROLACTIN LN 7K76-30 LN 89425UI00.; LN 7K76-30 LN 89425UI00.; SN ISR53565, ARCH PROLACTIN.; SN ISR53565.; ARCH I2000SR LN 03M74-02; LN 7K76-30 LN 89425UI00; SN (B)(4), ARCH PROLACTIN