MAUDE Adverse Event Report: MAGELLAN DIAGNOSTICS INC LEADCARE; LEADCARE II

Model Number N/A

Device Problem Nonstandard Device (1420)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/19/2021

Event Type  Injury  

Manufacturer Narrative

Fda's medical device reporting (mdr) team sent this adverse event report to magellan diagnostics, inc.With a cover letter dated december 7, 2021.The event was reported in medwatch report mw5104648 as having occurred on (b)(6) 2021 and magellan is filing this mdr as a report of a potential false negative result associated with the leadcare ii device and recall z-1952-2021 (res-87992).

Event Description

The following narrative is based on medwatch report mw5104648: "my baby took a lead test that was normal on (b)(6) 2021.The recall lead to a retest and her levels were elevated.We now have no idea if they were elevated back in (b)(6) which means 6 months of potential harm due to the failed test.Fda safety report id#(b)(4)".

• Brand Name: LEADCARE
• Type of Device: LEADCARE II
• Manufacturer (Section D): MAGELLAN DIAGNOSTICS INC; 101 billerica ave; bldg 4; north billerica MA 01862
• Manufacturer (Section G): MAGELLAN DIAGNOSTICS INC; 101 billerica ave; bldg 4; north billerica MA 01862
• Manufacturer Contact: charles thornton ; 101 billerica ave.; bldg 4; north billerica, MA 01862 ; 5132713700
• MDR Report Key: 13309794
• MDR Text Key: 284172270
• Report Number: 1218996-2022-00001
• Device Sequence Number: 1
• Product Code: DOF
• 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: Other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 01/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: N/A
• Device Catalogue Number: 70-6762
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: RES-87992
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention