MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-09-05 for CHOLESTECH LDX 14-697 manufactured by Alere San Diego, Inc.
[16536730]
Customer alleges sparks coming from one of two frayed power cords. Customer has more than one cholestech meter and cannot identify which power cord sparked.
Patient Sequence No: 1, Text Type: D, B5
[16667848]
Both power supply cables were damaged on the dc side by the converter box. Sparking was observed on one of the power supplies, when the cable with the damage was moved around. No other issue was observed during investigation. The power cord of the ldx, under extreme conditions of bending and manipulation, may eventually cut thereby exposing the copper wire being insulated. When the insulation breaks, it does so beside the strain relief of the dc cord. The ldx power cable for 9v dc was upgraded to address the cable breaking after the repeated bending. The risk associated was found to be low. Further investigation was performed in (b)(4) 2012. The risk associated with the sparking power cable was determined to be low. No further investigation will be pursued under this case number. The ldx power cable for 9v dc was upgraded to address the cable breaking after the repeated bending. The risk associated was found to be low. Corrective action not required at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027969-2012-01279 |
| MDR Report Key | 2742282 |
| Report Source | 05,06 |
| Date Received | 2012-09-05 |
| Date of Report | 2012-09-05 |
| Date of Event | 2012-07-31 |
| Date Mfgr Received | 2012-07-06 |
| Date Added to Maude | 2012-12-19 |
| 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 |
| Brand Name | CHOLESTECH LDX |
| Generic Name | CHOLESTEROL TEST |
| Product Code | CHH |
| Date Received | 2012-09-05 |
| Returned To Mfg | 2012-08-16 |
| Model Number | 14-697 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2012-09-05 |