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

Catalog Number 70-6762

Device Problems False Negative Result (1225); Improper or Incorrect Procedure or Method (2017); Device Handling Problem (3265)

Patient Problem No Information (3190)

Event Date 02/20/2018

Event Type  malfunction  

Manufacturer Narrative

Customer initially called on (b)(6) 2018 reporting run-time errors.During interview with product support it was discovered that the customer had not been following manufacturer's instructions for adding the quality control to the treatment reagent prior to testing.The instructions to properly prepare a quality control sample are found on page 3-2 of the leadcare ii user's guide.Upon further interview on (b)(6) 2018 it was discovered that the customer had not been adding patient samples to the treatment reagent prior to testing.The instructions to properly prepare a patient sample is found on page 4-6 of the leadcare ii user's guide.During the initial phone call on (b)(6) 2018 the customer was instructed on how to properly prepare samples and was able to get the quality controls in range.Customer was then contacted on (b)(4) 2018 to understand how the customer had been trained.Product support provided the customer with a leadcare ii quick reference guide and a package insert to further help with the training of the customer.(b)(4).

Event Description

Customer called reporting run-time errors.During call with product support customer stated they had not been using the treatment reagent and was applying the quality control directly to the sensor.Customer also stated they had been applying patient sample directly to the sensor as well without treatment reagent.

• 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: 7346300
• MDR Text Key: 102739885
• Report Number: 1218996-2018-00004
• 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: 03/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Assistant
• Device Expiration Date: 12/07/2018
• Device Catalogue Number: 70-6762
• Device Lot Number: 1711M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/07/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1