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

Model Number 70-6529

Device Problems Corroded (1131); Degraded (1153); Material Integrity Problem (2978)

Patient Problems Patient Problem/Medical Problem (2688); Test Result (2695)

Event Date 04/17/2019

Event Type  malfunction  

Manufacturer Narrative

User facility contacted magellan's product support team to report the instrument was generating a "used sensor" error message at the end of the countdown instead of a result.The user prepped and tested 3-4 sensors for the instrument, but the error message persisted.The instrument was returned to magellan.During investigative testing by magellan, the instrument generated a test failed error message for one sample (the event log showed the user encountered multiple errors) and out of range high results with three of four quality control (qc) samples run.In addition, the event logs indicate external qc was not consistently being performed in accordance with the manufacturer's instructions.Periodic testing with qc controls is used to monitor the instrument's performance.During visual inspection corrosion was noted on the sensor pins.Corrosion of the pins occurs when there is overexposure of the pins to the assay's acidic treatment reagent.This occurs when used test sensors are not removed immediately after testing (per instructions in the package insert) or when too much sample is added to the test sensors.No user, patient impact or harm was reported.However, because the instrument was able to generate results there is potential that an erroneous patient result was generated.Magellan provided the customer with a new instrument and additional information on proper analyzer maintenance.Case (b)(4).

Event Description

User facility contacted magellan's product support team to report the instrument was generating a "used sensor" error message at the end of the countdown instead of a result.

• 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: 8611452
• MDR Text Key: 145114554
• Report Number: 1218996-2019-00010
• 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: 05/15/2019

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 Model Number: 70-6529
• Device Catalogue Number: 70-6529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/17/2019
• Initial Date FDA Received: 05/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2012
• 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