MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-03-29 for ICON SC STREP A IMMUNOCHEMICAL TEST 395161 manufactured by Beckman Coulter Inc..
[1918277]
A customer contacted beckman coulter inc. , (bci) and stated that the icon sc strep a testing device gave negative (-) results on patients that were tested positive (+) on cultures. The false results were not reported out of the lab. Patients were given antibiotic treatments and are doing well. No effect to patients has been reported.
Patient Sequence No: 1, Text Type: D, B5
[9223939]
Investigation performed by bci using controls and low, medium and high positive calibrators gave expected results. A clear root cause for this event has not been determined to date.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2518658-2011-00005 |
| MDR Report Key | 2032176 |
| Report Source | 07 |
| Date Received | 2011-03-29 |
| Date of Report | 2011-03-01 |
| Date of Event | 2011-03-01 |
| Date Mfgr Received | 2011-03-01 |
| Device Manufacturer Date | 2009-07-27 |
| Date Added to Maude | 2012-02-08 |
| 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 BLVD. |
| 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 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ICON SC STREP A IMMUNOCHEMICAL TEST |
| Generic Name | IMMUNOCHEMICAL TEST |
| Product Code | GTY |
| Date Received | 2011-03-29 |
| Model Number | NA |
| Catalog Number | 395161 |
| Lot Number | 419G11 |
| Device Expiration Date | 2011-01-31 |
| 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 | 2011-03-29 |