MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-04-03 for SICKLEDEX TUBE TEST FOR HEMOGLOBIN S 773500 manufactured by Ortho-clinical Diagnostics, Inc..
[450313]
Customer reported a false negative result was obtained when the sample was tested with sickledex lot 5250. Customer results were satisfactory. Customer obtained a positive result for the patient's sample via electrophoresis. No death or serious injury is associated with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2250051-2006-50140 |
| MDR Report Key | 695791 |
| Date Received | 2006-04-03 |
| Date of Report | 2006-04-03 |
| Date of Event | 2006-03-02 |
| Date Added to Maude | 2006-04-06 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SICKLEDEX TUBE TEST FOR HEMOGLOBIN S |
| Generic Name | * |
| Product Code | GHM |
| Date Received | 2006-04-03 |
| Model Number | NA |
| Catalog Number | 773500 |
| Lot Number | 5250 |
| ID Number | NA |
| Device Expiration Date | 2006-09-08 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 684904 |
| Manufacturer | ORTHO-CLINICAL DIAGNOSTICS, INC. |
| Manufacturer Address | 1001 US HWY 202 RARITAN NJ 08869 US |
| Baseline Brand Name | SICKLEDEX |
| Baseline Generic Name | NA |
| Baseline Model No | NA |
| Baseline Catalog No | 773500 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-04-03 |