MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-07-25 for DIASCREEN 10 REAGENT STRIPS manufactured by Ark Ray Usa Inc..
[2783045]
Diascreen 10 reagent strips, lot 01042a, exp 05/2013 appeared to give false result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5026293 |
| MDR Report Key | 2675742 |
| Date Received | 2012-07-25 |
| Date of Report | 2012-07-25 |
| Date of Event | 2012-07-18 |
| Date Added to Maude | 2012-08-01 |
| 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 | 3 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIASCREEN 10 REAGENT STRIPS |
| Generic Name | REAGENT STRIPS |
| Product Code | CDM |
| Date Received | 2012-07-25 |
| Lot Number | 01042A |
| Device Expiration Date | 2013-05-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARK RAY USA INC. |
| Manufacturer Address | 5182 W 76TH MINNEAPOLIS MN 55439 US 55439 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-07-25 |