MAUDE Adverse Event Report: MAGELLAN DIAGNOSTICS 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 07/02/2018

Event Type  malfunction  

Manufacturer Narrative

Corrosion of the analyzer sensor pins were noted during evaluation of the analyzer, which is the most likely cause of the screen malfunction, error messages and failed qc results.Corrosion of the sensor pins occurs when there is over exposure of the analyzer pins to the assay's acidic treatment reagent.This occurs when used test sensors are not removed immediately after testing or when too much sample is added to the test sensor.Per sections 4-8 and 5-8 of the leadcare ii user's manual, "remove the used sensor immediately after recording the result." investigation of the event log showed the customer had been experiencing repeated run-time error messages prior to contacting magellan.(b)(4).

Event Description

A user facility called magellan's product support on (b)(6) 2018 to report that the message screen of their leadcare blood lead analyzer was not advancing properly from test step to test step.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 on (b)(6) 2018.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.There have been no reports of injuries or erroneous results reported by the user facility.

• Brand Name: LEADCARE II ANALYZER
• Type of Device: LEADCARE II
• Manufacturer (Section D): MAGELLAN DIAGNOSTICS; 101 billerica ave bldg 4; n. billerica MA 01862 1271
• Manufacturer (Section G): MAGELLAN DIAGNOSTICS; 101 billerica ave bldg 4; n. billerica MA 01862 1271
• Manufacturer Contact: eric bresnahan ; 101 billerica ave bldg 4; n. billerica, MA 01862-1271 ; 9782484815
• MDR Report Key: 7687682
• MDR Text Key: 114427152
• Report Number: 1218996-2018-00013
• Device Sequence Number: 1
• Product Code: DOF
• UDI-Device Identifier: 00850355006178
• UDI-Public: 00850355006178
• 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: 07/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 70-6529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2009
• 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