MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-09-05 for B-HEMOGLOBIN PHOTOMETER manufactured by Hemocue, Inc..
[16481565]
Results of a capillary specimen tested on device are unacceptably high when compared with a simultaneous venous specimen. This has the potential for allowing rptr to accept donors who would otherwise be deferred on the basis of a low hemoglobin. (*)
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1009861 |
| MDR Report Key | 36718 |
| Date Received | 1996-09-05 |
| Date of Report | 1996-08-29 |
| Date Added to Maude | 1996-09-09 |
| 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 | B-HEMOGLOBIN PHOTOMETER |
| Generic Name | HEMOGLOBIN PHOTOMETER |
| Product Code | KHG |
| Date Received | 1996-09-05 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 38121 |
| Manufacturer | HEMOCUE, INC. |
| Manufacturer Address | BOX 1204 S 26223 ANGELHOLM SW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-09-05 |