MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-04-11 for CHOLESTECH LDX 05625 10-004 manufactured by Cholestech Corp..
[15681368]
Cholesterol cassette - no reaction would occur. Cholesterol high and low controls were out of range.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1021594 |
| MDR Report Key | 326760 |
| Date Received | 2001-04-11 |
| Date of Report | 2001-04-05 |
| Date of Event | 2000-11-01 |
| Date Added to Maude | 2001-04-17 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHOLESTECH LDX |
| Generic Name | ANALYZER-CHOLESTEROL AND GLUCOSE |
| Product Code | JGY |
| Date Received | 2001-04-11 |
| Returned To Mfg | 2001-03-01 |
| Model Number | 05625 |
| Catalog Number | 10-004 |
| Lot Number | C08 3108 - 7 BOXES |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 316163 |
| Manufacturer | CHOLESTECH CORP. |
| Manufacturer Address | 3347 INVESTMENT BLVD HAYWARD CA 94545 US |
| Brand Name | CHOLESTECH LDX |
| Generic Name | ANALYZER - CHOLESTEROL & GLUCOSE |
| Product Code | JGY |
| Date Received | 2001-04-11 |
| Returned To Mfg | 2001-03-01 |
| Model Number | * |
| Catalog Number | 10-004 |
| Lot Number | C04 3211 - 22 BOXES |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 2 |
| Device Event Key | 316302 |
| Manufacturer | CHOLESTECH CORP |
| Manufacturer Address | 3347 INVESTMENT BLVD HAYWARD CA 94545 US |
| Brand Name | CHOLESTECH LDX |
| Generic Name | ANALYZER - CHOLESTEROL & GLUCOSE |
| Product Code | JGY |
| Date Received | 2001-04-11 |
| Returned To Mfg | 2001-03-01 |
| Model Number | * |
| Catalog Number | 10-004 |
| Lot Number | C11 3208 - 27 BOXES |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 3 |
| Device Event Key | 316303 |
| Manufacturer | CHOLESTECH CORP. |
| Manufacturer Address | 3347 INVESTMENT BLVD HAYWARD CA 94545 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-04-11 |