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	01/12/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mdr 1218996-2017-00041 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: 2.1 sample results after being held in treatment reagent for 24 hrs and tested, in ug/dl: 6.3 and 4.2 sample results after being held in treatment reagent for 48 hrs and tested, in ug/dl: 4.7.Patient 1 (sample 2): on leadcare ultra analyzer [not reportable] samples run immediately after preparation in treatment reagent, in ug/dl: 2.3 sample results after being held in treatment reagent for 24 hrs and tested, in ug/dl: 4.7.Patient 1 (sample 3): on leadcare ultra analyzer [not reportable] samples run immediately after preparation in treatment reagent, in ug/dl: 2.7 sample results after being held in treatment reagent for 24 hrs and tested, in ug/dl: 4.4.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 inaccuracy of the results and in accordance with our mdr decision tree these results would not be considered reportable.Comment: same device kit from customer could not be used.The lot 1404au 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.(b)(4).
Event or Problem Description
1218996-2017-00041 addendum blood/treatment reagent mixtures tested with leadcare ultra produce results at time t=0 that are lower than when the mixture is held and then tested at t=24, and t=48.

• 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: 9356610
• Report Number: 1218996-2019-00042
• Device Sequence Number: 14012455
• 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: Other Health Care Professional
• 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: 01/12/2015
• 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