MAUDE Adverse Event Report: MAGELLAN DIAGNOSTICS LEADCARE II ANALYZER

Catalog Number	70-6529-R
Medical Device Problem Codes	Bent (1059); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/15/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On examination of the returned analyzer, rust, corrosion, and bent pins were identified.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.The analyzer was generating error messages appropriately to alert customer to adverse conditions.Customer was not running qc according to manufacturer's instructions.When controls were run at magellan, the results were out of range low.No reported harm or injuries occurred as a result of this issue.Magellan provided the customer with a new instrument, additional training, and provided instructions on proper maintenance.No further issues of this nature have been shown for this customer.
Event or Problem Description
Customer was getting analyzer errors upon application of sample prep to sensor.In addition, during troubleshooting customer was getting qc out of range low.On examination it appeared that one analyzer pin was bent.Customer may not have been removing spent sensor immediately after testing.Customer was not always applying sample correctly.All qc results were out of range low upon testing by magellan.

• Brand Name: LEADCARE II ANALYZER
• Common Device Name: LEADCARE II
• Manufacturer (Section D): MAGELLAN DIAGNOSTICS; 101 billerica ave bldg 4; n. billerica MA 01862 1271
• MDR Report Key: 7135634
• Report Number: 1218996-2017-00015
• Device Sequence Number: 1327906
• Product Code: DOF
• UDI-Device Identifier: 00850355006178
• UDI-Public: 00850355006178
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K052549
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 70-6529-R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2016
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2016
• Initial Report FDA Received Date: 12/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1