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

Catalog Number 07P48-30

Device Problems Unable to Obtain Readings (1516); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 01/25/2019

Event Type  malfunction  

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.Removals and corrections report number: 3005094123-11/21/18-002-r.

Event Description

The customer observed error codes 5794 (reagent carousel load error) and 5672 (reagent supply center load error) while loading alinity i tsh reagent lot 92291ui00 on the alinity i processing module.There was no report of any patient impact due to the potential delay in generating tsh results.

• Brand Name: ALINITY I TSH
• Type of Device: TSH
• Manufacturer (Section D): A.I.D.D LONGFORD; lisnamuck; co. longford; longford NA ; EI NA
• Manufacturer (Section G): A.I.D.D LONGFORD; lisnamuck; co. longford; longford NA ; EI NA
• Manufacturer Contact: noemi romero-kondos, rn bsn ; 100 abbott park road; dept. 09b9, lccp1-3; abbott park, IL 60064-3537 ; 224667-512
• MDR Report Key: 8340170
• MDR Text Key: 136271662
• Report Number: 3005094123-2019-00056
• Device Sequence Number: 1
• Product Code: JLW
• UDI-Device Identifier: 00380740131159
• UDI-Public: 00380740131159
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/24/2019
• Device Catalogue Number: 07P48-30
• Device Lot Number: 92291UI00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: 3005094123-11/21/18-002R
• Patient Sequence Number: 1