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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 Electrical Shorting (2926); Noise, Audible (3273)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 06/27/2016
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Analyzer was evaluated upon return to manufacturer.At magellan analyzer powered on successfully using ac adapter.Intermittent issues in powering analyzer on using batteries.Analyzer made crackling noises when powered on with batteries in the left battery chamber.No indication of injury or harm to the user.Late filing is part of (b)(4).
 
Event or Problem Description
Instrument reported to generate 102 error codes.In addition, the ac adapter for analyzer became extremely hot.No user injury 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 Key7141900
Report Number1218996-2017-00008
Device Sequence Number1109527
Product Code DOF
UDI-Device Identifier00850355006178
UDI-Public00850355006178
Combination Product (Y/N)N
Initial Reporter StateNC
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 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 Number70-6529-R
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/06/2016
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/06/2016
Initial Report FDA Received Date12/22/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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