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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-R
Medical Device Problem Codes Failure to Power Up (1476); Smoking (1585)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 09/13/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Analyzer was in a lab affected by hurricane (b)(4).Analyzer had been unplugged during storm, but once it was plugged in, it began to smoke.This specific event could not be replicated at magellan.Analyzer would not power on.No indication of injury or harm to the user.Late filing is part of (b)(4).
 
Event or Problem Description
All laboratory equipment had been unplugged during hurricane (b)(4).The a/c adapter was left plugged into the surge protector, but not into the instrument.On reopening of laboratory, customer was plugging all equipment back into power supplies.On plugging the a/c adapter back into the analyzer, the analyzer began smoking.No injury or other adverse event was reported.
 
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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 Key7135786
Report Number1218996-2017-00011
Device Sequence Number86445
Product Code DOF
UDI-Device Identifier00850355006178
UDI-Public00850355006178
Combination Product (Y/N)N
Initial Reporter StateFL
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) 12/07/2017
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-R
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/22/2017
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/13/2017
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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