MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-10-09 for CARDINAL 6210KCA * manufactured by Inverness Medical.
[499030]
We had an incident where over thirty people had positive strep tests in one day. This seemed odd as most of the individuals were employees or our health center, and there was no reason to believe this was an epidemic of any kind. We performed controls twice on our test kit that day, and it performed normally. However, we decided to back up a number of the positive tests with cultures. These were our results: culture + -, rapid strep + 0 11, rapid strep - 0 5 16, specificity = 5/16 = 31%. The stated specificity of the test is 99% range 97. 6, 100% positive predictive value for the test was 0. The mfr is inverness medical. Product code is 6210kca. Test name sp strep a dipstick lot #93914 exp 12/07. They performed three negative controls using retention devices and they all performed normally. I suspect that there is something else going on -- cross reactivity with another antigen perhaps. Clearly there is something wrong with the in vivo performance of this test.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1040635 |
| MDR Report Key | 768099 |
| Date Received | 2006-10-09 |
| Date of Report | 2006-10-09 |
| Date of Event | 2006-08-16 |
| Date Added to Maude | 2006-10-11 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARDINAL |
| Generic Name | SP STREP A DINSTICK |
| Product Code | GTY |
| Date Received | 2006-10-09 |
| Model Number | 6210KCA |
| Catalog Number | * |
| Lot Number | 93914 |
| ID Number | * |
| Device Expiration Date | 2007-12-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 755976 |
| Manufacturer | INVERNESS MEDICAL |
| Manufacturer Address | 2 RESEARCH WAY PRINCETON NJ 08540 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-10-09 |