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	07/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported falsely elevated patient blood lead test results with leadcare ii.Customer reported blood lead test kit (lot 2602m, sublot unknown) level 1 and level 2 controls were within range upon opening according to package insert instructions.Customer reported level 1 control values of 10.7 ug/dl, 11.7 ug/dl and 10.8 ug/dl (target range of 8.8 to 14.8 ug/dl) on (b)(6) 2026, respectively.Customer reported level 2 control values of 29.6 ug/dl, 29.5 ug/dl and 28.8 ug/dl (target range of 27.1 to 35.9 ug/dl) on (b)(6) 2026, respectively.Customer reported an elevated leadcare ii pediatric patient blood lead test result of 3.7 ug/dl with corresponding confirmatory test result of less than 1.0 ug/dl.Customer reported hnl performed confirmation testing.Customer was unable to provide a copy of confirmation test results as results go directly into electronic patient charts.During troubleshooting technical services (ts) asked the customer to describe their method applied for collecting and preparing capillary blood.The customer described procedures that align with the instructions for use (ifu).Customer confirmed they do not use secondary micro-collection devices to collect patient samples.Customer reported bringing a single capillary tube and plunger along with the treatment reagent (tr) tube into the patient collection room.Ts recommended bringing the whole container of capillary tubes and plungers to avoid contamination.Customer reported using gloves without powder.Customer reported there was no construction taking place in the area of the facility.Customer reported their leadcare ii analyzer's sensor deck was clean and the prongs were golden.Customer reported they cleaned the sensor deck with an alcohol wipe.Ts recommended cleaning the sensor deck with a dry cloth.Customer reported using the ac adapter to power the leadcare ii analyzer.On (b)(6) 2026 the regional point of care (rpoc) visited the customer's facility.Rpoc reported the customer stocked the entire container of capillary tubes and plungers in the patient collection rooms.Magellan provided 5 additional sets of capillary tube and plunger containers to the customer to store in each patient collection room.On (b)(6) 2026 customer confirmed receipt of capillary tubes and plungers.Customer reported they would continue to monitor testing.On (b)(6) 2026 the customer reported testing was going well and they plan to monitor for an additional week.Ts to follow up.Magellan diagnostics received the customer's leadcare ii analyzer for further investigation on (b)(6) 2026.Ts attempted to follow up with the customer on (b)(6) 2026.No additional communication has been received by the customer to date.
Additional Manufacturer Narrative
This customer reported four (4) falsely elevated blood lead test results.This report documents one patient.Separate mdrs are filed for each of the patient results.The related report numbers are referenced in the respective 3500a forms 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: john lewis ; 101 billerica avenue, bldg. 4; north billerica, MA 01862
• MDR Report Key: 50437671
• Report Number: 1218996-2026-00311
• Device Sequence Number: 15680735
• 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
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 08/25/2026

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
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/20/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/28/2026
• Initial Report FDA Received Date: 08/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/25/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown