UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM A25640

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-03-25 for UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM A25640 manufactured by Beckman Coulter.

Event Text Entries

[41225156] A beckman coulter (bec) field service engineer (fse) was dispatched to assess the instrument's performance. The fse replaced the luminometer and performed a system check. The system check failed with low washed mean. The fse noted a slow aspirate peri pump tube and replaced it. The washed system check was performed and was passing within specifications. The cause of the erroneous access ferritin results is due to a hardware malfunction; however, no one component can be implicated as the sole contributor in this event.
Patient Sequence No: 1, Text Type: N, H10

[41225157] The customer reported obtaining erroneous ferritin (access ferritin) results in association with the laboratory's access 2 immunoassay system portion of the unicel dxc 600i synchron access clinical system (serial number (b)(4)) for several patients. The customer stated that failing access ferritin qc prompted patient samples to be repeated. Upon repeat of the samples for access ferritin, the customer noted a difference of 60-70 ng/ml between the repeated result and the original result. The customer stated the erroneous access ferritin results were reported from the laboratory. No corrected reports were sent as the customer believed the repeated results were not different enough to be significant to patient care. There was no change or impact to patient care or treatment in association with the erroneous access ferritin results. The customer declined to provide patient data. Calibration and quality control (qc) data were not provided for review. The customer stated that qc recovery was within range prior to the event but was failing the following day. Multiple system checks were reported to be failing washed %cv and substrate mean. During troubleshooting with the customer technical support (cts), the customer changed new aspirate probes, tightened substrate fitting, and changed the substrate probe. The system check was repeated and continued to fail with each of the changes. The patient samples were plasma samples with no reported sample integrity issues. The customer did not supply sample handling and processing information and did not supply the sample centrifugation parameters such as speed, time, and temperature. A beckman coulter (bec) field service engineer (fse) was dispatched to assess the instrument's performance.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2122870-2016-00163
• MDR Report Key: 5526696
• Report Source: HEALTH PROFESSIONAL,USER FACI
• Date Received: 2016-03-25
• Date of Report: 2016-03-01
• Date of Event: 2016-03-01
• Date Mfgr Received: 2016-03-01
• Device Manufacturer Date: 2009-02-23
• Date Added to Maude: 2016-03-25
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 0
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MR. JEFFREY KOLL
• Manufacturer Street: 1000 LAKE HAZELTINE DRIVE
• Manufacturer City: CHASKA MN 55318
• Manufacturer Country: US
• Manufacturer Postal: 55318
• Manufacturer Phone: 9523681361
• Manufacturer G1: BECKMAN COULTER
• Manufacturer Street: 1000 LAKE HAZELTINE DRIVE
• Manufacturer City: CHASKA 55318
• Manufacturer Country: US
• Manufacturer Postal Code: 55318
• Single Use: 3
• Previous Use Code: 3
• Removal Correction Number: NA
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 0

• Brand Name: UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM
• Generic Name: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE, PRODUCT CODE: JJE
• Product Code: JMG
• Date Received: 2016-03-25
• Model Number: NA
• Catalog Number: A25640
• Lot Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 0
• Device Event Key: 0
• Manufacturer: BECKMAN COULTER
• Manufacturer Address: 1000 LAKE HAZELTINE DRIVE CHASKA 55318 US 55318

Device Sequence Number: 1

• Brand Name: UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM
• Generic Name: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE, PRODUCT CODE: JJE
• Product Code: JJE
• Date Received: 2016-03-25
• Model Number: NA
• Catalog Number: A25640
• Lot Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BECKMAN COULTER
• Manufacturer Address: 1000 LAKE HAZELTINE DRIVE CHASKA 55318 US 55318

Patients

Patient Number	Treatment	Outcome	Date
1	0		2016-03-25