MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-07-29 for MULTISTIX 2300A manufactured by Ames Diagnostics Div. Miles Labs, Inc..
[6333]
Urinalysis showed wbc too numerous to count but this device showed "negative," then on repeat, "trace" wbc at 2 minutes (when supposed to be read).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4000462 |
| MDR Report Key | 15076 |
| Date Received | 1994-07-29 |
| Date of Report | 1994-05-10 |
| Date of Event | 1994-05-10 |
| Date Added to Maude | 1994-08-08 |
| 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 | MULTISTIX |
| Product Code | JJW |
| Date Received | 1994-07-29 |
| Catalog Number | 2300A |
| Lot Number | A767023 |
| Device Expiration Date | 1994-08-01 |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 15070 |
| Manufacturer | AMES DIAGNOSTICS DIV. MILES LABS, INC. |
| Manufacturer Address | ELKHART IN 46515 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-07-29 |