MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION 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)
Date of Event	04/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information: no further patient information was provided by the customer.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed a falsely elevated architect prolactin result for 1 sample when compared to beckman analyzer.The following data was provided (reference range: 5.18 to 26.53 ng/ml): (b)(6) initial result = 130 ng/ml, repeat = 136.83 ng/ml, beckman = 31.48 ng/ml (within their reference range).No impact to patient management was reported.
Additional Manufacturer Narrative
A review of tracking and trending did not identify any trends for the complaint issue.Return testing was not completed as returns were not available.Accuracy testing was performed using a retained kit of lot 07218ui00.All specifications were met indicating that the lot is performing acceptably.To further investigate the customer's issue, the historical performance of reagent lot 07218ui00 was evaluated using worldwide data.The patient median results for lot 07218ui00 are comparable with other lots in the field and confirms no systemic issue for the lot.Device history record review on lot 07218ui00 did not show any potential non-conformances, or deviations.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.A review of labeling concluded that the issue is sufficiently addressed.Based on the investigation no systemic issue or deficiency of the architect prolactin for lot number 07218ui00 was identified.

• Brand Name: ARCHITECT PROLACTIN
• Common Device Name: PROLACTIN
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION LONGFORD; lisnamuck; co. longford; longford NA ; EI NA
• MDR Report Key: 10003466
• Report Number: 3005094123-2020-00094
• Device Sequence Number: 11282141
• 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): 06/04/2020

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: 07/30/2020
• Device Model Number: 7K76-35
• Device Catalogue Number: 07K76-35
• Device Lot Number: 07218UI00
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/21/2020
• Supplement Date Received by Manufacturer: 06/03/2020
• Initial Report FDA Received Date: 04/27/2020
• Supplement Report FDA Received Date: 06/04/2020
• 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, SERIAL (B)(6) ; LIST 03M74-02,SERIAL (B)(6)