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

Model Number 70-6529

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458)

Patient Problems No Consequences Or Impact To Patient (2199); Test Result (2695)

Event Date 11/19/2019

Event Type  malfunction  

Manufacturer Narrative

User facility first contacted magellan's product support team to report they were encountering high patient results.However, upon review of their data the firm encountered one suppressed result.The user recorded a 3.6 ug/dl result for patient #1 (reference lab results were 39.8, 41.0, and 33.9 ug/dl) on instrument s/n: (b)(4).The analyzer, ac adaptor and test kits 1915m -07 and 1908m-06 were returned to magellan for evaluation.Upon receipt of the returned items, magellan conducted testing to confirm the reported issue.However, the firm's test results did not confirm the reported failure of a suppressed result for either the returned kits or the returned analyzer.Magellan did verify that the user properly followed the instructions for use of controls with no unusual results.The controls were within range.No user or patient impact or harm was reported, the issue is currently still under investigation.Case (b)(4).

Event Description

User facility first contacted magellan's product support team to report they were encountering high patient results.However, upon review of their data the firm encountered one suppressed result.

• Brand Name: LEADCARE II BLOOD LEAD TEST SYSTEM
• Type of Device: LEADCARE II ANALYZER
• 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: ivy margaret thiong'o ; 101 billerica ave; building 4; n. billerica, MA 01862 ; 9783135480
• MDR Report Key: 9488391
• MDR Text Key: 204992397
• Report Number: 1218996-2019-00062
• Device Sequence Number: 1
• Product Code: DOF
• UDI-Device Identifier: 00850355006017
• UDI-Public: 00850355006017
• 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: Nurse
• Type of Report: Initial
• Report Date: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 70-6529
• Device Catalogue Number: 70-6529
• Device Lot Number: WLC05513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1