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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
Catalog Number 70-6529
Device Problems Failure to Sense (1559); Device Sensing Problem (2917)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/07/2015
Event Type  malfunction  
Manufacturer Narrative
A user facility called magellan's product support to report error messages on their leadcare ii analyzer.There was no indication at the time of the report that the analyzer was reporting erroneous results.The analyzer was returned to magellan for evaluation.During investigative testing, magellan observed repeated failed external control tests.A review of the analyzer's event logs showed that the instrument had generated numerous error messages over several months while in use at the user facility but these had not been reported to magellan as specified in product labeling.In addition, the event logs indicate that external qc was not consistently being performed on a monthly basis in accordance with label instructions.Corrosion was noted on sensor pins.Corrosion of the sensor pins occurs when there is overexposure of the analyzer pins to the assay's acidic treatment reagent.This occurs when used test sensors are not removed immediately after testing (per instrument instructions) or when too much sample is added to the test sensor.Periodic testing with blood lead qc controls is used to monitor analyzer performance.Here have been no reports of injuries or erroneous results reported by the user facility.Note: late filing is part of magellan diagnostics, inc.Response to fda's 483 issued on (b)(4) 2017.(b)(4).Customer complaint: (b)(4).
 
Event Description
A user facility called magellan's product support on to report test failed error messages on their leadcare blood lead analyzer.
 
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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 Key8027078
MDR Text Key127248825
Report Number1218996-2018-00031
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 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 Catalogue Number70-6529
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/12/2015
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/07/2015
Initial Date FDA Received10/31/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/26/2008
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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