MAUDE Adverse Event Report: MAGELLAN DIAGNOSTICS LEADCARE II ANALYZER

Catalog Number 70-6529-R

Device Problems Electrical Shorting (2926); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/27/2016

Event Type  malfunction  

Manufacturer Narrative

Analyzer was evaluated upon return to manufacturer.At magellan analyzer powered on successfully using ac adapter.Intermittent issues in powering analyzer on using batteries.Analyzer made crackling noises when powered on with batteries in the left battery chamber.No indication of injury or harm to the user.Late filing is part of (b)(4).

Event Description

Instrument reported to generate 102 error codes.In addition, the ac adapter for analyzer became extremely hot.No user injury reported.

• 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: 7141900
• MDR Text Key: 95955809
• Report Number: 1218996-2017-00008
• Device Sequence Number: 1
• Product Code: DOF
• UDI-Device Identifier: 00850355006178
• UDI-Public: 00850355006178
• 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
• Type of Report: Initial
• Report Date: 12/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 70-6529-R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2010
• 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