MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-09-16 for ICON DS STREP A manufactured by Beckman Coulter.
[19177340]
Beckman coulter icon ds strep a. This is a point-of-care rapid test to diagnose strep throat. The printing on the test strips is upside-down as compared to the procedure card -in the box- examples. If someone were to hold the strip in a way that allowed them to read the words "control" and "test" while trying to follow the card instructions, they could read a negative test as positive, and vice versa. Diagnosis or reason for use: rapid strep test for diagnosis of strep throat.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5008325 |
| MDR Report Key | 1164224 |
| Date Received | 2008-09-16 |
| Date of Report | 2008-09-16 |
| Date Added to Maude | 2008-09-24 |
| 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 | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ICON DS STREP A |
| Generic Name | NONE |
| Product Code | GTY |
| Date Received | 2008-09-16 |
| Lot Number | 426H11 |
| Device Expiration Date | 2008-02-29 |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1193358 |
| Manufacturer | BECKMAN COULTER |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-09-16 |