MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-10-03 for SICKLEDEX TUBE TEST OF HEMOGLOBIN S NI 773200 manufactured by Ortho-clinical Diagnostics, Inc..
[331644]
Customer reported that a pt sample that reacted positive in may is now reacting negative. No reported death or serious injury was associated with this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2250051-2003-01134 |
| MDR Report Key | 490468 |
| Date Received | 2003-10-03 |
| Date of Report | 2003-09-30 |
| Date of Event | 2003-09-04 |
| Date Facility Aware | 2003-09-09 |
| Report Date | 2003-09-30 |
| Date Added to Maude | 2003-10-23 |
| 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 | 0 |
| 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 OF HEMOGLOBIN S |
| Generic Name | NA |
| Product Code | GHM |
| Date Received | 2003-10-03 |
| Model Number | NI |
| Catalog Number | 773200 |
| Lot Number | 3070 |
| ID Number | NA |
| Device Expiration Date | 2004-02-26 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 18 MO |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 479200 |
| Manufacturer | ORTHO-CLINICAL DIAGNOSTICS, INC. |
| Manufacturer Address | 1001 US HWY 202 RARITAN NJ 088690606 US |
| Baseline Brand Name | SICKLEDEX TUBE TEST FOR HEMOGLOBIN S |
| Baseline Generic Name | BLOOD GROUPING REAGENT |
| Baseline Model No | NA |
| Baseline Catalog No | 773200 |
| Baseline ID | NA |
| Baseline Device Family | NA |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 12 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-10-03 |