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

Model Number 70-6529-R

Device Problems Electrical /Electronic Property Problem (1198); Failure to Run on Battery (1466); Battery Problem (2885)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/03/2019

Event Type  malfunction  

Manufacturer Narrative

User facility contacted magellan's product support team to report the instrument emitted a "fizzing" noise once new pro-cell (b)(6) double aa batteries were installed into the battery board compartment.Then, the user noticed fluid leaking from the left side of the battery board compartment.The user also stated, they did not proceed to power on the instrument after encountering this issue.However, they did install the same batteries into two other leadcare ii instruments.The same issue occurred.This instrument was returned to magellan for evaluation.During investigative testing by magellan, it was noted that the returned instrument (s/n: (b)(4)) would not power on with two installed batteries on the left side of the battery board chamber, but it would power on with two batteries on the right side.The instrument also powered on with the returned leadcare ac adapter.Battery acid residue was visible on the left side of the battery board compartment.Battery leakage upon initial insertion is generally associated with use error, specifically not inserting the batteries according to the diagram on the analyzer.No user or patient impact or harm was reported.(b)(4).

Event Description

User facility contacted magellan's product support team to report the instrument emitted a "fizzing" noise once pro-cell (b)(6) double aa batteries were installed into the battery board compartment.Then, the user noticed fluid leaking from the battery board compartment.The user also stated, they installed the same batteries into two other leadcare ii units.The same issue occurred.

• 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: heather reed ; 101 billerica ave; building 4; n. billerica, MA 01862 ; 9782484811
• MDR Report Key: 8569855
• MDR Text Key: 153132527
• Report Number: 1218996-2019-00007
• 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: 05/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 70-6529-R
• Device Catalogue Number: 70-6529-R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2015
• 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