MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-05-12 for LDX 14-973 manufactured by Alere San Diego, Inc..
[2145778]
Customer reported ldx printer power cord was smoking, possibly from where the parts connect to the black box. They had an electrician come out and inspect the power outlet and it was determined to be functioning properly.
Patient Sequence No: 1, Text Type: D, B5
[9052210]
Investigation pending.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027969-2011-01077 |
| MDR Report Key | 2100128 |
| Report Source | 05 |
| Date Received | 2011-05-12 |
| Date of Report | 2011-05-12 |
| Date of Event | 2011-04-21 |
| Date Mfgr Received | 2011-04-21 |
| Date Added to Maude | 2011-06-13 |
| 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 |
| Removal Correction Number | NI |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LDX |
| Generic Name | CHOLESTEROL METER POWER SUPPLY |
| Product Code | CHH |
| Date Received | 2011-05-12 |
| Returned To Mfg | 2011-05-02 |
| Model Number | 14-973 |
| Lot Number | NG |
| 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 | 2011-05-12 |