MAUDE Adverse Event Report: MAGELLAN DIAGNOSTICS LEADCARE II ANALYZER

Catalog Number	70-6529- R
Medical Device Problem Codes	Failure to Sense (1559); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/12/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analyzer was returned to magellan for further investigation.Confirmation testing could not be performed due to analyzer errors being generated.Confirmed customer's issue through review of the error logs for the analyzer.Corrosion of analyzer sensor pins was identified during instrument repair.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.(b)(4).Late filing is part of magellan diagnostics, inc.Response to fda's 483 issued on 29jun2017.
Event or Problem Description
Customer started experiencing "system failed" messages during startup of the analyzer.In these cases, the analyzer will not generate results.The analyzer error log shows that analyzer errors were generated in large numbers prior to the complaint call.Analyzer was performing as expected in generating those error messages however customer continued to run the analyzer.Review of analyzer event logs also showed the customer was not consistently running periodic qc according to the manufacturer's instructions.When customer did run controls they were out of range.No reported injuries occurred as a result of this issue.

• Brand Name: LEADCARE II ANALYZER
• Common Device Name: LEADCARE II
• Manufacturer (Section D): MAGELLAN DIAGNOSTICS; 101 billerica ave bldg 4; n. billerica MA 01862 1271
• MDR Report Key: 7142096
• Report Number: 1218996-2017-00024
• Device Sequence Number: 1108878
• Product Code: DOF
• UDI-Device Identifier: 00850355006178
• UDI-Public: 00850355006178
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K052549
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/22/2017

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
• Operator of Device: Health Professional
• Device Catalogue Number: 70-6529- R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2016
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2016
• Initial Report FDA Received Date: 12/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1