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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 BLOOD LEAD TEST KIT

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MAGELLAN DIAGNOSTICS, INC. LEADCARE II BLOOD LEAD TEST SYSTEM; LEADCARE® II BLOOD LEAD TEST KIT Back to Search Results
Catalog Number 70-6762
Device Problem False Negative Result (1225)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/21/2011
Event Type  malfunction  
Manufacturer Narrative
During investigative testing, (b)(4) observed repeated failed external control tests.An internal study confirmed the field performance found by some customers with 1004a that there is an elevated bias in the low concentration range compared to earlier lots, however, it should be noted that lot 1004a gives results within the accuracy of leadcare test.(b)(4).
 
Event Description
A user facility called (b)(4) product support to report they were receiving controls out of range, reporting results of 5.0 to 6.0 g/dl on approximately 50 % of tests run.Confirmation tests resulted in "low" < 3.3g/dl.
 
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Brand Name
LEADCARE II BLOOD LEAD TEST SYSTEM
Type of Device
LEADCARE® II BLOOD LEAD TEST KIT
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 Key8027047
MDR Text Key126383528
Report Number1218996-2018-00026
Device Sequence Number1
Product Code DOF
UDI-Device Identifier00850355006000
UDI-Public00850355006000
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 10/31/2018
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
Device Operator Other
Device Expiration Date10/14/2011
Device Catalogue Number70-6762
Device Lot Number1004A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/08/2011
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/21/2011
Initial Date FDA Received10/31/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/14/2010
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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