MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-07-23 for SICKLEDEX TUBE TEST OF HEMOGLOBIN S NI 773500 manufactured by Ortho-clinical Diagnostics, Inc..
[301804]
Customer reported that two specimens from individuals known to be positive for sickle cell trait tested negative with this product. No reported death or serious injury was associated with this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2250051-2003-00920 |
| MDR Report Key | 473997 |
| Date Received | 2003-07-23 |
| Date of Report | 2003-07-15 |
| Date of Event | 2002-12-16 |
| Date Added to Maude | 2003-07-29 |
| 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 | 2003-07-23 |
| Model Number | NI |
| Catalog Number | 773500 |
| Lot Number | 2015 |
| ID Number | NA |
| Device Expiration Date | 2003-01-09 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 462849 |
| Manufacturer | ORTHO-CLINICAL DIAGNOSTICS, INC. |
| Manufacturer Address | 1001 US HWY 202 RARITAN NJ 088690606 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-07-23 |