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 Consequences Or Impact To Patient (2199)
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 stated that a falsely elevated architect prolactin result of 1205.58 miu/ml was generated for a patient sample that tested at 392 miu/ml (within normal range) using the beckman prolactin method.No adverse impact to patient management was reported.
Additional Manufacturer Narrative
An investigation of the customer issue included a review of the complaint text, a search and review of similar complaints, a review of labeling, accuracy testing, a review of instrument logs, and a review of field data.There was no unusual complaint activity found for architect prolactin reagent lot 05259ui00.There were no trends identified when tracking and trending was reviewed.Labeling was found to be adequate.Accuracy testing was performed using a retained kit of the reagent lot number and it met all specifications.A review of the instrument logs through abbott link found no issues relevant to the customer complaint.Also, a review of field data found no similar issues.Based on all available information and abbott diagnostics' complaint investigation, no product deficiency 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: 9617555
• Report Number: 3005094123-2020-00021
• Device Sequence Number: 10899326
• 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): 03/31/2020

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: 05259UI00
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/05/2020
• Supplement Date Received by Manufacturer: 03/27/2020
• Initial Report FDA Received Date: 01/22/2020
• Supplement Report FDA Received Date: 03/31/2020
• 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 ANALYZER; ARCHITECT I2000SR LIST 03M74-02,; LN03M74-02, (B)(6); SERIAL (B)(6)