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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 Battery Problem (2885); Noise, Audible (3273)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 01/30/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
No device failure of the leadcare ii, however batteries ruptured.Cause for ruptured batteries could not be determined.Evidence of battery corrosion inside the battery compartment.Analyzer was able to be powered on through ac/dc plug and alternatively, with batteries.Could not replicate the customer's issue.No indication of injury or harm to the user.Case number: (b)(4).Late filing is part of (b)(4).
 
Event or Problem Description
Customer attempted to power the analyzer on with batteries installed, heard a sizzling noise from the battery compartment, and verified that the batteries were leaking into the compartment.No harm or injuries to the user were 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 Key7141964
Report Number1218996-2017-00013
Device Sequence Number13730480
Product Code DOF
UDI-Device Identifier00850355006178
UDI-Public00850355006178
Combination Product (Y/N)N
Initial Reporter StatePA
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 Health Professional
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 Manufacturer02/07/2017
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/30/2017
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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