LDX PRINTER 12642

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 2012-06-21 for LDX PRINTER 12642 manufactured by Alere San Diego, Inc..

Event Text Entries

[2765323] Customer alleged that the ldx printer had a burning smell upon turning on. The burning smell appeared to be coming from the plug, and the plug was hot. The printer was turned off and unplugged. Customer was sent a replacement printer.
Patient Sequence No: 1, Text Type: D, B5

[10060771] Investigation pending.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 2027969-2012-00962
• MDR Report Key: 2627135
• Report Source: 05,06
• Date Received: 2012-06-21
• Date of Report: 2012-06-21
• Date of Event: 2012-05-23
• Date Mfgr Received: 2012-05-23
• Date Added to Maude: 2012-10-15
• 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
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Contact: CARMEN BERGELIN, MGR.
• Manufacturer Street: 9975 SUMMERS RIDGE RD
• Manufacturer City: SAN DIEGO CA 92121
• Manufacturer Country: US
• Manufacturer Postal: 92121
• Manufacturer Phone: 8588052256
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: LDX PRINTER
• Generic Name: CHOLESTECH
• Product Code: CHH
• Date Received: 2012-06-21
• Model Number: 12642
• Lot Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ALERE SAN DIEGO, INC.
• Manufacturer Address: 9975 SUMMERS RIDGE RD SAN DIEGO CA 92121 US 92121

Patients

Patient Number	Treatment	Outcome	Date
1	0		2012-06-21