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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAGELLAN DIAGNOSTICS, INC. LEADCARE II BLOOD LEAD TEST SYSTEM; LEADCARE II ANALYZER
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MAGELLAN DIAGNOSTICS, INC. LEADCARE II BLOOD LEAD TEST SYSTEM; LEADCARE II ANALYZER Back to Search Results
Model Number 70-6529
Device Problems Failure to Run on Battery (1466); Battery Problem (2885)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 01/08/2019
Event Type  malfunction  
Manufacturer Narrative
The user facility contacted magellan's product support team to report the instrument would not power on.While changing the old batteries the customer noticed one of the batteries exhibited corrosion.The customer cleaned the battery board compartment and installed new batteries, and noted the analyzer would not power on but the batteries were hot to the touch and the instrument started to emit an electrical burning smell.Customer verbally stated the batteries were installed appropriately.Returned analyzer was tested by installing new batteries (industrial (b)(6)) into each side of the battery board compartment.The installed batteries did not power the instrument on, and did not replicate the report of emitting heat or electrical odor.The analyzer did power on with the returned ac adapter.Confirmed that there was no user impact or harm.Case number: (b)(4).
 
Event Description
The user facility contacted magellan's product support team to report the instrument would not power on.While changing the old batteries the customer noticed one of the batteries exhibited corrosion.The customer cleaned the battery board compartment and installed new batteries, and noted the analyzer would not power on but the batteries were hot to the touch and the instrument started to emit an electrical odor.Customer verbally stated the batteries were installed appropriately.Confirmed that there was no user impact or harm.
 
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Brand Name
LEADCARE II BLOOD LEAD TEST SYSTEM
Type of Device
LEADCARE II ANALYZER
Manufacturer (Section D)
MAGELLAN DIAGNOSTICS, INC.
101 billerica ave
building 4
n. billerica MA 01862
Manufacturer (Section G)
MAGELLAN DIAGNOSTICS, INC.
101 billerica ave
building 4
n. billerica MA 01862
Manufacturer Contact
heather reed
101 billerica ave
building 4
n. billerica, MA 01862
9782484811
MDR Report Key8315629
MDR Text Key138138982
Report Number1218996-2019-00003
Device Sequence Number1
Product Code DOF
UDI-Device Identifier00850355006017
UDI-Public00850355006017
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K052549
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/07/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number70-6529
Device Catalogue Number70-6529
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/16/2019
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/08/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/22/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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