MAUDE Adverse Event Report: A.I.D.D LONGFORD ALINITY I FERRITIN

Catalog Number	07P65-30
Medical Device Problem Codes	Unable to Obtain Readings (1516); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A product recall letter was issued to customers who received shipments of the affected alinity reagents to inform them of the manufacturing issue identified with the reagent cartridge bottle necks.The letter instructs the customer to manually inspect each reagent cartridge in inventory before use.Stat assays, alinity i stat high sensitive troponin-i and alinity i total b-hcg, should be inspected first as a priority to ensure no delay in testing for those assays.Complete removals and corrections report number: 3005094123-11/21/18-002-r.
Event or Problem Description
The customer observed error codes 5652, 5662 and 5819 related to reagent cartridge loading while attempting to load alinity i ferritin reagent lot 91532ui00 on the alinity i processing module.There was no report of any patient impact due to the potential delay in generating ferritin results.

• Brand Name: ALINITY I FERRITIN
• Common Device Name: FERRITIN
• Manufacturer (Section D): A.I.D.D LONGFORD; lisnamuck; co. longford; longford NA ; EI NA
• MDR Report Key: 8550231
• Report Number: 3005094123-2019-00134
• Device Sequence Number: 368058
• Product Code: DBF
• UDI-Device Identifier: 00380740131487
• UDI-Public: 00380740131487
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 04/25/2019

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: 06/30/2019
• Device Catalogue Number: 07P65-30
• Device Lot Number: 91532UI00
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2019
• Initial Report FDA Received Date: 04/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3005094123-11/21/18-002R
• Patient Sequence Number: 1