MAUDE Adverse Event Report: Magellan Diagnostics, Inc. LeadCare II Blood Lead Testing System; Blood Lead Analyzer

Catalog Number	70-6760
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported presumed falsely elevated patient blood lead test results with leadcare ii.On customer reported level 1 and level 2 controls were outside range on (b)(6) 2026 according to test kit package insert instructions: level 1 = "low" (target range = 4.9 to 10.9 ug/dl) and level 2 = "low" (target range = 21.5 to 29.5 ug/dl).Customer reported controls previously were within the range on (b)(6) 2026.Customer was unable to provide previous control values.Customer reported the blood lead test kit in use as lot 2609m-01 and leadcare ii analyzer as serial number (b)(6).Customer reported they are not the end user that performs patient testing with leadcare ii.Customer stated the nurse that performs testing is unavailable.Technical services (ts) requested a call with end user to review their method for collecting and preparing capillary blood.Customer reported testing was performed on a pediatric patient sample which resulted in a leadcare ii value of "low".Customer re-performed testing with the same sample which resulted in a leadcare ii value of 33.0 ug/dl.Customer performed testing a third time with the same sample which resulted in a leadcare ii value of "low".Customer reported patient was not sent for confirmation testing.Ts stated patient samples should not be tested more than once using the same treatment reagent (tr) tube.Ts scheduled a replacement leadcare ii analyzer to be sent to the customer.On (b)(6) 2026 ts provided the cdc capillary collection video and cdc guidelines for capillary blood lead collection.On (b)(6) 2026 customer confirmed receipt of replacement leadcare ii analyzer.Customer reported level 1 and level 2 controls were within range according to package insert instructions.Customer reported to be satisfied with assistance provided by ts.Customer's leadcare ii analyzer received at magellan for investigation on 08-sep-2026.

• 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: 50858157
• Report Number: 1218996-2026-00381
• Device Sequence Number: 15959034
• Product Code: DOF
• UDI-Device Identifier: 00850355006017
• UDI-Public: 00850355006017
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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): 09/22/2026

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: 09/08/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2016
• 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