MAUDE Adverse Event Report: MAGELLAN DIAGNOSTICS LEADCARE II CONSUMABLE; LEADCARE II TEST KIT

Catalog Number 70-6762

Device Problems Improper or Incorrect Procedure or Method (2017); Low Test Results (2458); Improper Chemical Reaction (2952)

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

Event Date 07/11/2016

Event Type  malfunction  

Manufacturer Narrative

Customer reported that all blood levels, including qc, were out of range low.During phone troubleshooting with customer the cause was identified as user error in not following manufacturer's instructions for sample preparation.No report of injuries or harm as a result of this incident.Customer results corrected by magellan product support personnel with a discussion of proper technique.(b)(4).Late filing is part of magellan diagnostics, inc.Response to fda's 483 issued on (b)(4) 2017.

Event Description

Customer reported all control and patient results were out of range low.During troubleshooting it was discovered that the user was not mixing the blood sample (or qc) with the treatment reagent prior to applying the test sample to the sensor.The result of not using the treatment reagent would be that all results would be out of range low on the analyzer.

• Brand Name: LEADCARE II CONSUMABLE
• Type of Device: LEADCARE II TEST KIT
• 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: 7141979
• MDR Text Key: 95791372
• Report Number: 1218996-2017-00017
• Device Sequence Number: 1
• Product Code: DOF
• UDI-Device Identifier: 00850355006000
• UDI-Public: 00850355006000
• 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 Expiration Date: 06/02/2017
• Device Catalogue Number: 70-6762
• Device Lot Number: 1512M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/11/2017
• Was Device Evaluated by Manufacturer?: No
• 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