MAUDE Adverse Event Report: MAGELLAN DIAGNOSTICS, INC. LEADCARE II BLOOD LEAD TEST SYSTEM; LEADCARE II ANALYZER

Catalog Number 70-2232

Device Problems Failure to Sense (1559); Device Sensing Problem (2917)

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

Event Date 09/01/2010

Event Type  malfunction  

Manufacturer Narrative

Erratic results were reported from the user, the customer indicated the analyzer is old, and was seeking to buy a replacement.Through interviewing the user, it was noted the sensor connector had corrosion.Corrosion was noted on sensor pins.Corrosion of the sensor pins occurs when there is overexposure of the analyzer pins to the assay's acidic treatment reagent.This occurs when used test sensors are not removed immediately after testing (per instrument instructions) or when too much sample is added to the test sensor.Periodic testing with blood lead qc controls is used to monitor analyzer performance.No reported harm or injuries occurred as a result of this issue.(b)(4).

Event Description

Customer reported observation of erratic results, for example the same sample with 2 analyzers yielded >65 and 2.6 on one analyzer and a 2.8 on a second analyzer.

• Brand Name: LEADCARE II BLOOD LEAD TEST SYSTEM
• Type of Device: LEADCARE II ANALYZER
• Manufacturer (Section D): MAGELLAN DIAGNOSTICS, INC.; 101 billerica ave; building 4; n. billerica MA 01862
• Manufacturer (Section G): MAGELLAN DIAGNOSTICS, INC.; 101 billerica ave; building 4; n. billerica MA 01862
• Manufacturer Contact: heather reed ; 101 billerica ave.; building 4; n. billerica, MA 01862 ; 9782484811
• MDR Report Key: 8027110
• MDR Text Key: 126383509
• Report Number: 1218996-2018-00036
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 70-2232
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2010
• 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