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

Model Number	70-8090
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/28/2014
Type of Reportable Event	Malfunction
Additional 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; 2.1 vs 5.4 [1218996-2019-00057]; 3.5 vs 7.8 [1218996-2019-00058]; 1.8 vs 5.1 [1218996-2019-00059]; 3.9 vs 6.5 [1218996-2019-00060].
Event or Problem 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
• Common Device Name: LEADCARE ULTRA TEST KIT
• Manufacturer (Section D): MAGELLAN DIAGNOSTICS, INC.; 101 billerica ave.; building 4; n. billerica MA 01862
• MDR Report Key: 9356613
• Report Number: 1218996-2019-00056
• Device Sequence Number: 10880055
• Product Code: DOF
• UDI-Device Identifier: 00850355006024
• UDI-Public: 00850355006024
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K123563
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 11/21/2019

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: 10/25/2015
• Device Model Number: 70-8090
• Device Catalogue Number: 70-8090
• Device Lot Number: 1404AU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2014
• Initial Report FDA Received Date: 11/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1