MAUDE Adverse Event Report: MAGELLAN DIAGNOSTICS, INC. LEADCARE ULTRA CONSUMABLE; LEADCARE ULTRA TEST KIT

Model Number 70-8090

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/28/2014

Event Type  malfunction  

Manufacturer Narrative

Mdr 1218996-2017-00040 addendum: magellan's investigations have confirmed that extended incubation (ie overnight) of blood/treatment reagent mixtures at room temperature or incubation at high temperatures (ie, 60 c) improved test results for some blood specimens.Studies suggest the venous blood collection tube contributes to the low results as similar low results are not observed with capillary blood samples.Magellan has since determined the root cause of suppressed results with venous bloods samples to be directly related to a material change in the rubber stopper of the bd blood collection tube kit.Current labeling indicates that venous samples should not be used on the leadcare system.Same device kit from customer could not be used.The lot 1404au materials were from magellan inventory.Case number; (b)(4).Late filing is part of magellan diagnostics, inc.Response to fda's 483 issued on 29jun2017.Testing was all done on (b)(6) 2014 and patient sample results for lcu vs icp-ms (in ug/dl) were all filled under one mdr.We will now be submitting separate mdrs for each individual patient result.Results: (lcu vs icp-ms).4.3 vs 6.4 [1218996-2019-00055]; 4.6 vs 7.3 [1218996-2019-00056]; 2.1 vs 5.4 [1218996-2019-00057]; 3.5 vs 7.8 [1218996-2019-00058]; 1.8 vs 5.1; 3.9 vs 6.5 [1218996-2019-00060].

Event Description

Mdr 1218996-2017-00040 addendum: samples tested with leadcare ultra produced results that were low when compared to the reference method icp/ms.

• Brand Name: LEADCARE ULTRA CONSUMABLE
• Type of Device: LEADCARE ULTRA TEST KIT
• Manufacturer (Section D): MAGELLAN DIAGNOSTICS, INC.; 101 billerica ave.; building 4; n. billerica MA 01862
• Manufacturer (Section G): MAGELLAN DIAGNOSTICS, INC.; 101 billerica ave; building 4; n. billerica MA 01862
• Manufacturer Contact: ivy margaret thiong'o ; 101 billerica ave; building 4; n. billerica, MA 01862 ; 9783135480
• MDR Report Key: 9356617
• MDR Text Key: 220629196
• Report Number: 1218996-2019-00059
• Device Sequence Number: 1
• Product Code: DOF
• UDI-Device Identifier: 00850355006024
• UDI-Public: 00850355006024
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123563
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/25/2015
• Device Model Number: 70-8090
• Device Catalogue Number: 70-8090
• Device Lot Number: 1404AU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/28/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/25/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1