MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-01-04 for SICKLE CELL BUFFER UNK manufactured by Columbia Diagnostics.
[202164]
Reagent used for sickle cell testing. Mfr instructions state result can be read within 2 to 5 mins. Rptr read a positive at 5 mins and electrophoresis gave normal result (neg). The following day 2 others gave same results. Contact mfr that admitted that lot number was slow. A 4th test was totally positive at 5 mins but negative by eight mins. Mfr suggested to wait 15 mins for this lot. Mfr to send a substitute lot but rptr has not yet received it.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1020748 |
| MDR Report Key | 310967 |
| Date Received | 2001-01-04 |
| Date of Report | 2001-01-04 |
| Date of Event | 2000-12-18 |
| Date Added to Maude | 2001-01-08 |
| 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 | SICKLE CELL BUFFER |
| Generic Name | TESTING REAGENT |
| Product Code | GHM |
| Date Received | 2001-01-04 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | 0272 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 300814 |
| Manufacturer | COLUMBIA DIAGNOSTICS |
| Manufacturer Address | * SPRINGFIELD VA * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2001-01-04 |