MAUDE Adverse Event Report: MAGELLAN DIAGNOSTICS, INC. LEADCARE II BLOOD LEAD TESTING SYSTEM; BLOOD LEAD ANALYZER

Catalog Number	70-6760
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported seen elevated blood lead patient results with leadcare ii.Customer reported leadcare ii test results were not confirmed by laboratory (venous) testing.The number of elevated test results or values and kit lot numbers involved in the event have not been provided or made available to magellan at the time of the report.As part of troubleshooting conducted the designated leadcare ii representative (rpoc), the rpoc reported customer was using paper towels to dry patients' hands and was not wiping excess from capillary tube before plunging to tr tube as indicated in ifu.Rpoc provided re-training on (b)(6) 2026.Rpoc also reported battery corrosion in the leadcare analyzer in use, and noted batteries were not actively leaking, corrosion was white and dry and crusty.Rpoc removed batteries and instructed the customer to use either batteries or power cord, not both at the same time, as indicated in the user's manual.Rpoc ran controls while onsite and they were in range.At the time magellan submitted the initial mdr to report this event (1218996-2026-00089) magellan's post market surveillance team had been unable to collect patient results information.During follow up the customer provided the following update: patient leadcare ii blood lead test result was 4.7 ug/dl, while confirmation test result was <1.0 ug/dl.
Additional Manufacturer Narrative
The customer's update to this event included retrospective report of two elevated patient results.This report documents only one patient result a separate mdr is filed for the additional patient test result.The related report numbers are referenced in the 3500a form for traceability.

• Brand Name: LEADCARE II BLOOD LEAD TESTING SYSTEM
• Common Device Name: BLOOD LEAD ANALYZER
• Manufacturer (Section D): MAGELLAN DIAGNOSTICS, INC.; 101 billerica avenue, bldg. 4; north billerica MA 01862
• Manufacturer (Section G): MAGELLAN DIAGNOSTICS, INC.; 101 billerica avenue, bldg. 4; north billerica MA 01862
• Manufacturer Contact: vernon brown ; 101 billerica avenue, bldg. 4; north billerica, MA 01862 ; 9789543699
• MDR Report Key: 24749810
• Report Number: 1218996-2026-00122
• Device Sequence Number: 8771819
• Product Code: DOF
• UDI-Device Identifier: 00850355006017
• UDI-Public: 00850355006017
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K052549
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/31/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: 70-6760
• Initial Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown