MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-08-10 for CHOLESTECH LDX 14-874 manufactured by Alere San Diego, Inc..
[2852626]
Caller alleged that the cholestech ldx meter would not power on. Results as follows: customer reports that the ldx meter will not power on. During call, customer tried multiple power sources and the transformer on power cable began smoking. Technical services informed the customer to remove the meter from the power source. No report of death or serious injury. Replacement meter is being sent to the customer.
Patient Sequence No: 1, Text Type: D, B5
[10024324]
Investigation pending.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027969-2012-01188 |
| MDR Report Key | 2696045 |
| Report Source | 06 |
| Date Received | 2012-08-10 |
| Date of Report | 2012-08-09 |
| Date of Event | 2012-07-16 |
| Date Mfgr Received | 2012-07-16 |
| Date Added to Maude | 2012-11-29 |
| 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, MANAGER |
| 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 |
| Brand Name | CHOLESTECH LDX |
| Generic Name | CHOLESTEROL METER |
| Product Code | CHH |
| Date Received | 2012-08-10 |
| Returned To Mfg | 2012-08-07 |
| Model Number | 14-874 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALERE SAN DIEGO, INC. |
| Manufacturer Address | SAN DIEGO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-08-10 |