MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-10-17 for CHOLESTECH LDX 14-874 manufactured by Alere San Diego, Inc..
[3093671]
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.
Patient Sequence No: 1, Text Type: D, B5
[10233323]
Investigation pending.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027969-2012-01526 |
| MDR Report Key | 2801088 |
| Report Source | 05,06 |
| Date Received | 2012-10-17 |
| Date of Report | 2012-10-17 |
| Date of Event | 2012-09-24 |
| Date Mfgr Received | 2012-10-10 |
| Date Added to Maude | 2013-01-30 |
| 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, REGULATORY COMP |
| Manufacturer Street | 9975 SUMMERS RIDGE ROAD |
| 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 |
| Brand Name | CHOLESTECH LDX |
| Generic Name | CHOLESTEROL METER |
| Product Code | CHH |
| Date Received | 2012-10-17 |
| Model Number | 14-874 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALERE SAN DIEGO, INC. |
| Manufacturer Address | SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-10-17 |