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

Model Number 70-6529-P

Device Problems Imprecision (1307); Calibration Problem (2890)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/17/2018

Event Type  malfunction  

Manufacturer Narrative

1218996-2018-00040 addendum.Customer called indicating their leadcare ii capillary results inconsistent with venous reference results.These results were collected over a year time period, and traceability to the lots used during testing are not available for investigative evaluation.The unit was returned for testing after the original mdr [1218996-2018-00040] was submitted on 17nov2018.Testing performed: test 2 sets of whole blood patient samples in duplicates on both returned analyzer wlc09319 and in house analyzer wlc00105 against gfaas results.Conclusion: all qc and whole blood samples tested on both the in-house analyzer and returned analyzer generated results that correlated well with gfaas no reported harm or injuries occurred as a result of this issue.Customer coplaint: (b)(6).After further investigation it has been confirmed that none of the blood lead sample results are considered reportable events.Data below: sample 1: leadcare ii 7.1ug/dl vs labcorp: 10 ug/dl, not reportable, sample 2: leadcare ii 5.1 ug/dl vs labcorp: 11 ug/dl, not reportable, sample 3: leadcare ii: 8.5 ug/dlvs labcorp: 11 ug/dl, not reportable, sample 4: leadcare ii: 9.5 ug/dl vs labcorp: 13 ug/dl.Not reportable.

Event Description

1218996-2018-00040 addendum.Customer called requesting information on correlation to reference laboratories on (b)(6) 2018.After further verbal discussion the customer provided data on (b)(6) 2018 indicating erroneous patient results over the course of a year.

• 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: 9150897
• MDR Text Key: 220250803
• Report Number: 1218996-2019-00019
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 70-6529-P
• Device Catalogue Number: 70-6529-P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2016
• 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