CHOLESTECH 14-697

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 2011-06-17 for CHOLESTECH 14-697 manufactured by Alere San Diego, Inc..

Event Text Entries

[2115512] Caller reports that the power supply cord is frayed towards the middle. The wires are exposed. A replacement power supply has been ordered for the customer.
Patient Sequence No: 1, Text Type: D, B5

[9281919] The customer did not return the damaged power supply. Unable to pursue further investigation without return. Complaint will be tracked and trended. Corrective action not required at this time.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 2027969-2011-01356
• MDR Report Key: 2158743
• Report Source: 05,06
• Date Received: 2011-06-17
• Date of Report: 2011-06-17
• Date of Event: 2011-05-24
• Date Mfgr Received: 2011-05-24
• Date Added to Maude: 2011-08-09
• 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: 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: CHOLESTECH
• Generic Name: CHOLESTEROL METER
• Product Code: CHH
• Date Received: 2011-06-17
• Model Number: 14-697
• 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: SAN DIEGO CA US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2011-06-17