MAUDE Adverse Event Report: MAGELLAN DIAGNOSTICS, INC. LEADCARE II BLOOD LEAD TEST SYSTEM; LEADCARE II ANALYZER

Model Number 70-6529

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

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

Event Date 10/24/2014

Event Type  malfunction  

Manufacturer Narrative

Mdr 1218996-2018-00022 addendum: user facility contacted magellan's product support team to report suppressed blood lead results on the leadcare ii blood lead analyzer when compared to reference lab results.Visual inspection of the returned leadcare ii analyzer confirmed corrosion on the sensor pins.Corrosion of the sensor pins typically occurs when there is overexposure of the analyzer pins to the assay's acidic treatment reagent.This occurs when used test sensors are not removed immediately after testing (per instrument instructions) or when too much sample is added to the test sensor.Also, periodic testing with blood lead qc controls is used to monitor analyzer performance after investigation it was determined that the user did not perform qc as intended.Magellan provided the customer with a new instrument, and additional training.No reported harm or injuries occurred as a result of this issue.Note: late filing is part of magellan diagnostics, inc.Response to fda's 483 issued on (b)(6) 2017.(b)(4).Patient sample results for lcu vs (b)(6) (in ug/dl) were all filled under one mdr.We will now be submitting separate mdrs for each individual patient result.Results: (lcu vs (b)(6)).9.9 vs15.0 [1218996-2019-00043]; 18.1 vs 21.0 [1218996-2019-00044]; 18.1 vs 23.0 [1218996-2019-00045].Customer complaint: (b)(4).

Event Description

Mdr 1218996-2018-00022 addendum: user facility contacted magellan's product support team to report suppressed blood lead results on the leadcare ii blood lead analyzer when compared to reference lab results.

• Brand Name: LEADCARE II BLOOD LEAD TEST SYSTEM
• Type of Device: LEADCARE II ANALYZER
• 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: 9356619
• MDR Text Key: 220627808
• Report Number: 1218996-2019-00045
• Device Sequence Number: 1
• Product Code: DOF
• UDI-Device Identifier: 00850355006017
• UDI-Public: 00850355006017
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052549
• 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

• 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 Model Number: 70-6529
• Device Catalogue Number: 70-6529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1