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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAGELLAN DIAGNOSTICS LEADCARE II ANALYZER
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MAGELLAN DIAGNOSTICS LEADCARE II ANALYZER Back to Search Results
Catalog Number 70-6529
Medical Device Problem Codes Electrical Shorting (2926); Noise, Audible (3273)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 11/30/2015
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Analyzer was returned for evaluation.Reportable event was associated with power on of the analyzer, and resulted in sizzling / crackling electrical sounds.This specific event could not be replicated at magellan.No indication of injury or harm to the user.Late filing is part of (b)(4).
 
Event or Problem Description
Sizzling, crackling, electrical sounds were heard when the analyzer was rebooted.
 
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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 Key7135539
Report Number1218996-2017-00006
Device Sequence Number1211076
Product Code DOF
UDI-Device Identifier00850355006178
UDI-Public00850355006178
Combination Product (Y/N)N
Initial Reporter StateVA
Initial Reporter CountryUS
PMA/510(K) Number
K052549
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Medical Assistant
Type of Report Initial
Report Date (Section B) 12/06/2017
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 Number70-6529
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/21/2016
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/21/2016
Initial Report FDA Received Date12/20/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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