MAUDE Adverse Event Report: MAGELLAN DIAGNOSTICS LEADCARE II ANALYZER

Catalog Number 70-6529

Device Problems Failure to Power Up (1476); Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/19/2018

Event Type  malfunction  

Manufacturer Narrative

Customer stated the analyzer had emitted smoke from the battery compartment.Upon removal of the batteries from the battery compartment the analyzer performed as expected with the a/c adapter.Information related to proper battery placement was not obtained at the time of reporting, however during the investigative process it was noted after battery insertion the analyzer would not power on.Quality control testing was conducted using an ac adaptor and the analyzer performed as expected.The sensor pins were examined during the investigation, and no corrosion was noted.There was no report from the customer of impact to patient results.Customer has received a new analyzer and has been trained on proper use of batteries and the a/c adapter for the leadcare ii analyzer.(b)(4).

Event Description

Customer stated the analyzer had emitted smoke from the battery compartment.Upon removal of the batteries from the battery compartment the analyzer performed as expected with the a/c adapter.No user or patient harm noted.

• Brand Name: LEADCARE II ANALYZER
• Type of Device: LEADCARE II
• Manufacturer (Section D): MAGELLAN DIAGNOSTICS; 101 billerica ave bldg 4; n. billerica MA 01862 1271
• Manufacturer (Section G): MAGELLAN DIAGNOSTICS; 101 billerica ave bldg 4; n. billerica MA 01862 1271
• Manufacturer Contact: eric bresnahan ; 101 billerica ave bldg 4; n. billerica, MA 01862-1271 ; 9782484815
• MDR Report Key: 7523598
• MDR Text Key: 108904072
• Report Number: 1218996-2018-00006
• 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: Health Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 70-6529
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/19/2018
• 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