MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-09-15 for CHOLESTECH 14-874 manufactured by Alere San Diego, Inc..
[2349314]
Returned power cords received on (b)(6) 2011 for reported poor design. No mention of sparking was made in reference to the returned power supplies at this time. Twenty-four additional power supplies were received in product support (b)(6) 2011. Customer reported on (b)(6) 2011 that they have a power cord that sparked due to fraying at the adaptor. Customer wraps the power cords around the meter when moving from screening site to screening site. Customer did not know which cord had caused the sparking.
Patient Sequence No: 1, Text Type: D, B5
[9310210]
Investigation pending.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027969-2011-01980 |
| MDR Report Key | 2281116 |
| Report Source | 05,06 |
| Date Received | 2011-09-15 |
| Date of Report | 2011-09-16 |
| Date of Event | 2011-04-11 |
| Date Mfgr Received | 2011-08-17 |
| Date Added to Maude | 2011-11-28 |
| 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 |
| Generic Name | CHOLESTEROL METER |
| Product Code | CHH |
| Date Received | 2011-09-15 |
| Returned To Mfg | 2011-06-22 |
| Model Number | 14-874 |
| Lot Number | NG |
| 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 | 2011-09-15 |