MAUDE Adverse Event Report: MAGELLAN DIAGNOSTICS, INC. 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 09/05/2018

Event Type  malfunction  

Manufacturer Narrative

Customer reported "test failed" error message multiple times when depositing blood/treatment reagent mixture to the sensor.Customer continued to repeat test until a patient result was achieved.The leadcare ii user's guide specifies "if an error message is encountered repeatedly, contact product support".Review of the analyzer event logs showed the customer had not run the qc controls according to the manufacturer's instructions since may 15, 2018.Periodic testing with blood lead qc controls is used to monitor analyzer performance.Testing of the returned unit at magellan did not replicate the error message, however testing of qc controls produced results outside of the expected range.During visual inspection corrosion was noted on the 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.No reported harm or injuries occurred as a result of this incident, however because the analyzer was able to generate a failing result for the controls there is a potential an erroneous patient result could be generated.Magellan provided the customer with a new instrument and additional information on proper analyzer maintenance.Case number: (b)(4).

Event Description

Customer reported "test failed" error message multiple times when depositing blood/treatment reagent mixture to the sensor.Customer continued to repeat test until a patient result was achieved.The leadcare ii user's guide specifies "if an error message is encountered repeatedly, contact product support".

• Brand Name: LEADCARE II ANALYZER
• Type of Device: LEADCARE II
• Manufacturer (Section D): MAGELLAN DIAGNOSTICS, INC.; 101 billerica ave; building 4; north billerica 01862
• Manufacturer (Section G): MAGELLAN DIAGNOSTICS, INC.; 101 billerica ave; building 4; north billerica MA 01862 1271
• Manufacturer Contact: heather reed ; 101 billerica ave; building 4; north billerica, MA 01862 ; 9782484811
• MDR Report Key: 7929906
• MDR Text Key: 122654632
• Report Number: 1218996-2018-00014
• 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: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2018
• 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: 09/24/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/28/2011
• 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