MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-12-30 for ICON SC STREP A IMMUNOCHEMICAL TEST 395161 manufactured by Beckman Coulter Inc..
[1766042]
A customer contacted beckman coulter inc. (bci) stating that the icon sc strep a testing device gave negative (-) results on patients that were tested positive (+) on cultures. Cultures were done based on the appearance of the patient (s) throat. The false results were not reported out of the laboratory. No death or serious injury was associated with this event. However, patients were given treatment following positive (+) culture results.
Patient Sequence No: 1, Text Type: D, B5
[8873080]
This issue is currently pending investigation on a test device return.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2518658-2010-00011 |
| MDR Report Key | 1943157 |
| Report Source | 05 |
| Date Received | 2010-12-30 |
| Date of Report | 2010-12-03 |
| Date of Event | 2010-12-03 |
| Date Mfgr Received | 2010-12-03 |
| Device Manufacturer Date | 2009-12-14 |
| Date Added to Maude | 2012-01-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS NORA ZEROUNIAN |
| Manufacturer Street | 250 S KRAEMER BOULEVARD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| Manufacturer G1 | BECKMAN COULTER INC. |
| Manufacturer Street | 606 ELMWOOD AVE. |
| Manufacturer City | SHARON HILL PA 19079103 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19079 1031 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ICON SC STREP A IMMUNOCHEMICAL TEST |
| Generic Name | IMMUNOCHEMICAL TEST |
| Product Code | GTY |
| Date Received | 2010-12-30 |
| Model Number | NA |
| Catalog Number | 395161 |
| Lot Number | 419M21 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER INC. |
| Manufacturer Address | 606 ELMWOOD AVE. SHARON HILL PA 19079103 US 19079 1031 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-12-30 |