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

Catalog Number 70-6529

Device Problems Failure to Sense (1559); Device Sensing Problem (2917)

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

Event Date 05/07/2015

Event Type  malfunction  

Manufacturer Narrative

A user facility called magellan's product support to report error messages on their leadcare ii analyzer.There was no indication at the time of the report that the analyzer was reporting erroneous results.The analyzer was returned to magellan for evaluation.During investigative testing, magellan observed repeated failed external control tests.A review of the analyzer's event logs showed that the instrument had generated numerous error messages over several months while in use at the user facility but these had not been reported to magellan as specified in product labeling.In addition, the event logs indicate that external qc was not consistently being performed on a monthly basis in accordance with label instructions.Corrosion was noted on sensor pins.Corrosion of the sensor pins 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.Periodic testing with blood lead qc controls is used to monitor analyzer performance.Here have been no reports of injuries or erroneous results reported by the user facility.Note: late filing is part of magellan diagnostics, inc.Response to fda's 483 issued on (b)(4) 2017.(b)(4).Customer complaint: (b)(4).

Event Description

A user facility called magellan's product support on to report test failed error messages on their leadcare blood lead analyzer.

• 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: heather reed ; 101 billerica ave.; building 4; n. billerica, MA 01862 ; 9782484811
• MDR Report Key: 8027078
• MDR Text Key: 127248825
• Report Number: 1218996-2018-00031
• 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: 10/31/2018

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: Other
• Device Catalogue Number: 70-6529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/07/2015
• Initial Date FDA Received: 10/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2008
• 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