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

Catalog Number	07K76-30
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All available patient information was included.Additional patient details are not available.An evaluation is in process.A final report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed a falsely elevated prolactin result on the architect i2000sr analyzer.The following data was provided: initial greater than 200, repeated 326, 14.40 ng/ml.Progesterone results of 16.04 and 12.30 ng/ml were also provided.The patient was on the following medications: levothyroxine, cyclobenzaprine, domperidone, glucosamine.There was no impact to patient management reported.
Additional Manufacturer Narrative
Catalog number, size, and code was updated from 07k76-35 to 07k76-30.Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of instrument logs, a review of labeling and accuracy testing.No adverse trend was identified for the customer's issue.Labeling was reviewed and found to be adequate.The product was not available for return.An internal panel was tested with retained kits of the likely cause reagent lot and accuracy testing met all specifications.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): A.I.D.D LONGFORD; lisnamuck; co. longford; longford NA ; EI NA
• MDR Report Key: 8092216
• Report Number: 3005094123-2018-00157
• Device Sequence Number: 1279607
• Product Code: CFT
• UDI-Device Identifier: 00380740105990
• UDI-Public: 00380740105990
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 02/17/2019

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: 03/12/2019
• Device Catalogue Number: 07K76-30
• Device Lot Number: 86008UI00
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/31/2018
• Supplement Date Received by Manufacturer: 02/15/2019
• Initial Report FDA Received Date: 11/20/2018
• Supplement Report FDA Received Date: 02/17/2019
• 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 ANALYZER; ARCHITECT I2000SR ANALYZER; LN 03M74-02 SN (B)(4) ; LN 03M74-02 SN (B)(4)