CX GLUCOSE REAGENT 442640

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-02-03 for CX GLUCOSE REAGENT 442640 manufactured by Beckman Coulter, Inc..

Event Text Entries

[2512685] On (b)(4) 2012, customer reported that she received a glucose reagent cartridge that had leaked due to a loose cap. No exposure or injuries were reported and no erroneous patient results were generated. Beckman coulter sent a replacement cartridge to the customer.
Patient Sequence No: 1, Text Type: D, B5

[9589748] (b)(4).
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 2050012-2012-00361
• MDR Report Key: 2438830
• Report Source: 05,06
• Date Received: 2012-02-03
• Date of Report: 2012-01-18
• Date of Event: 2012-01-18
• Date Mfgr Received: 2012-01-18
• Date Added to Maude: 2012-08-13
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Contact: MS. DUNG NGUYEN
• Manufacturer Street: 250 SOUTH KRAEMER BOULEVARD
• Manufacturer City: BREA CA 92821
• Manufacturer Country: US
• Manufacturer Postal: 92821
• Manufacturer Phone: 7149614941
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: CX GLUCOSE REAGENT
• Generic Name: HEXOKINASE, GLUCOSE
• Product Code: CKA
• Date Received: 2012-02-03
• Catalog Number: 442640
• Lot Number: M110253
• Device Expiration Date: 2013-11-30
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BECKMAN COULTER, INC.
• Manufacturer Address: 250 SOUTH KRAEMER BLVD. BREA CA 92821 US 92821

Patients

Patient Number	Treatment	Outcome	Date
1	0		2012-02-03