MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-05-18 for ICON DS STREP A 395098 manufactured by Beckman Coulter, Inc..
[2000840]
A customer contacted beckman coulter inc. (bci) in regards to (b)(6) swab (-) results obtained from icon ds strep a for twelve patients. The results were not reported out of the laboratory. The twelve patients were (b)(6) on cultures. There was no report of death or injury associated with this event.
Patient Sequence No: 1, Text Type: D, B5
[9007436]
The sample was throat swab. Retain devices tested by bci using controls and low, medium, and high calibrators produced expected results. The customer complaint was not confirmed. The customer will return the kit box for investigation. A clear root cause for this event has not been determined to date.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2518658-2011-00010 |
| MDR Report Key | 2094406 |
| Report Source | 05,06 |
| Date Received | 2011-05-18 |
| Date of Report | 2011-04-19 |
| Date of Event | 2011-04-19 |
| Date Mfgr Received | 2011-04-19 |
| Device Manufacturer Date | 2010-05-04 |
| Date Added to Maude | 2012-02-06 |
| 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 | 3 |
| 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 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ICON DS STREP A |
| Generic Name | STREP A TEST |
| Product Code | GTY |
| Date Received | 2011-05-18 |
| Model Number | NA |
| Catalog Number | 395098 |
| Lot Number | 420E21 |
| ID Number | NA |
| Device Expiration Date | 2011-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 | 2011-05-18 |