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

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 08/13/2014

Event Type  malfunction  

Manufacturer Narrative

Mdr 1218996-2017-00035 addendum.User notified magellan to indicate results were "not matching up".The dates for these tests are on or around (b)(6) 2014.Patient 1 (sample 1): on leadcare ultra analyzer [not reportable].Samples run immediately after preparation in treatment reagent, in ug/dl: 3.2.Sample results after being held in treatment reagent for 72 hrs and tested, in ug/dl: 7.7.Patient 1 (sample 2): on leadcare ultra analyzer [not reportable].Samples run immediately after preparation in treatment reagent, in ug/dl: 3.2.Sample results after being held in treatment reagent for 1hr and tested, in ug/dl: 6.6.Patient 1 (sample 3): on leadcare ultra analyzer [not reportable].Samples run immediately after preparation in treatment reagent, in ug/dl: 3.2.Sample results after being held in treatment reagent for 1hr and tested, in ug/dl: 6.6.After further investigation, it has been determined that the reported blood lead sample.Data above was produced by the leadcare.Ultra instrument only.The samples were never re-tested using a standard reference method to get a "true" sample level, as a result there was no confirmation as to the inacuracy of the results and in accordance with our mdr decision tree these results would not be considered reportable.Same device kit from customer could not be used.The lot 1312bu materials were from magellan inventory.The customer's inventory was exhausted.Late filing is part of magellan diagnostics, inc.Response to fda's 483 issued on 29jun2017.Complaint # (b)(4).

Event Description

Mdr 1218996-2017-00035 addendum.Customer reported samples tested immediately after addition to treatment reagent produce lower blood lead values than when they are allowed to sit for 1 hour, 24 hours, or 72 hours in the treatment reagent before testing.

• Brand Name: LEADCARE ULTRA CONSUMABLE
• Type of Device: LEADCARE ULTRA,
• 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 01826 ; 9783135480
• MDR Report Key: 9356620
• MDR Text Key: 220773365
• Report Number: 1218996-2019-00041
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2015
• Device Model Number: 70-8090
• Device Catalogue Number: 70-8090
• Device Lot Number: 1312BU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/13/2014
• Initial Date FDA Received: 11/21/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/30/2013
• 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