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

Catalog Number 70-6762

Device Problems False Negative Result (1225); Device Handling Problem (3265)

Patient Problem No Information (3190)

Event Date 12/15/2017

Event Type  malfunction  

Manufacturer Narrative

Customer had been collecting underfilled capillary samples (1/3 to 1/2 filled) and continued to run samples on the leadcare system.Magellan representative discussed the importance of a proper blood draw and provided customer with additional capillary tubes to practice getting an appropriate blood draw.Customer was made aware of the need to retest patients through a letter sent by magellan.

Event Description

New user of lead care ii, ran an estimated 5 patient samples, but acknowledged she was having trouble getting the capillary tubes to fill all the way with blood.She ran the samples anyway, with less than required amount of blood.It is a known risk that underfilled capillary tubes will lead to falsely suppressed patient results.She has been filling the capillary tubes just 1/3 to 1/2 full.Magellan has recommended that the user retest previously tested patients at risk.No further information available at this time.

• 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: 7178180
• MDR Text Key: 96842934
• Report Number: 1218996-2018-00001
• 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: Medical Assistant
• Type of Report: Initial
• Report Date: 01/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Assistant
• Device Catalogue Number: 70-6762
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/15/2017
• Was Device Evaluated by Manufacturer?: No
• 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