FDA Adverse Event
Malfunction
Summary report: N
CHOLESTECH LDX
MDR report key: 2801088
·
Received October 17, 2012
Report
- Report Number
- 2027969-2012-01526
- Event Type
- Malfunction
- Date Received
- October 17, 2012
- Date of Event
- September 24, 2012
- Report Date
- October 17, 2012
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- CHH
- PMA / PMN Number
- K901900
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
CALLER ALLEGED THAT THEY HAVE FRAYED POWER CORDS. RESULTS AS FOLLOWS: CUSTOMER REPORTS HAVING 5 FRAYED CHOLESTECH LDX POWER CORDS. A FEW WEEKS AGO TWO NURSES FELT A SHOCK POWERING ON TWO DIFFERENT CHOLESTECH LDX METERS. CUSTOMER STATED OF THE 5 POWER CORDS, THE MOST FRAYED CORDS CAUSED THE SHOCK. NO INJURIES OCCURRED AS A RESULT OF THE ¿SHOCKS¿, AND MEDICAL ATTENTION WAS NOT NEEDED. CUSTOMER BELIEVES THE POWER CORDS FRAYED FROM WEAR AND TEAR OVER TIME. IT IS NOT KNOWN HOW LONG THE POWER CORDS HAVE BEEN IN USE. TECHNICAL SERVICES IS SENDING REPLACEMENT POWER CORDS TO THE CUSTOMER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CHOLESTECH LDX | CHOLESTEROL METER | CHH | ALERE SAN DIEGO, INC. | 14-874 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |