MAUDE Adverse Event Report: MAGELLAN DIAGNOSTICS, INC. LEADCARE ULTRA CONSUMABLES

Model Number	LEADCARE ULTRA
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/22/2014
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mdr 1218996-2017-00038 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 is continuing investigations on to determine root cause of suppressed results with venous bloods.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 1312bu materials were from magellan inventory.Customer's inventory was exhausted.Late filing is part of magellan diagnostics, inc.Response to fda's 483 issued on 29jun2017.Testing was all done on (b)(6) 2017 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): 2 vs 10.5 , 3.8 vs 9.8 [1218996-2019-00017], 4.2 vs 8.7 [1218996-2019-00021], 2 vs 6.5 [1218996-2019-00022], 2 vs 6.6 [1218996-2019-00023], 2.5 vs 8.7 [1218996-2019-00024], 2 vs 6 [1218996-2019-00025].15.6 vs 21.2 [1218996-2019-00026], 15.4 vs 20.6 [1218996-2019-00027].After further investigation it has been confirmed that some of the blood lead sample results are not considered reportable events.Data below: 7.7 vs 14.6 [not reportable], 5.1 vs 10.6 [not reportable], 9.2 vs 16.1 [not reportable], 2 vs 4.6 [not reportable].
Event or Problem Description
Mdr 1218996-2017-00038 addendum.Customer reported that results of samples tested by leadcare ultra were low compared to an older model of the device and icp-ms.

• Brand Name: LEADCARE ULTRA CONSUMABLES
• Common Device Name: LEADCARE ULTRA
• Manufacturer (Section D): MAGELLAN DIAGNOSTICS, INC.; 101 billerica ave.; building 4; n. billerica MA 01862
• MDR Report Key: 9159270
• Report Number: 1218996-2019-00016
• Device Sequence Number: 19476677
• Product Code: DOF
• UDI-Device Identifier: 00850355006024
• UDI-Public: 00850355006024
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 10/04/2019

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: 06/30/2015
• Device Model Number: LEADCARE ULTRA
• Device Catalogue Number: 70-8098
• Device Lot Number: 1312BU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2014
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2014
• Initial Report FDA Received Date: 10/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1