MAUDE Adverse Event Report: MAGELLAN DIAGNOSTICS, INC. LEADCARE II BLOOD LEAD TEST SYSTEM; LEADCARE® II BLOOD LEAD TEST KIT

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.

• 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 Key: 8027047
• MDR Text Key: 126383528
• Report Number: 1218996-2018-00026
• Device Sequence Number: 1
• Product Code: DOF
• UDI-Device Identifier: 00850355006000
• UDI-Public: 00850355006000
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052549
• Number of Events Reported: 1
• 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 Date: 10/14/2011
• Device Catalogue Number: 70-6762
• Device Lot Number: 1004A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2011
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2011
• Initial Date FDA Received: 10/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1