MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-04-25 for ICON H PYLORI (P) KIT ICON HP 395160 manufactured by Beckman Coulter Inc..
[1851339]
A customer contacted beckman coulter inc. (bci) stating that the icon h pylori (p) test was generating discrepant results, where the whole blood tested negative and the serum was tested positive. Tests were repeated and gave positive results as expected. No patient sample information was supplied. No injury has been reported in connection with this event.
Patient Sequence No: 1, Text Type: D, B5
[9186646]
Investigation by (b)(4) with retain and return devices using controls and confirmed positive calibrators exhibited expected results. No patient sample was available for investigation. Complaint not confirmed, as devices perform as expected.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2518658-2011-00008 |
| MDR Report Key | 2067677 |
| Report Source | 06 |
| Date Received | 2011-04-25 |
| Date of Report | 2011-03-25 |
| Date of Event | 2011-03-18 |
| Date Mfgr Received | 2011-03-25 |
| Device Manufacturer Date | 2010-04-09 |
| 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 | 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 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ICON H PYLORI (P) KIT |
| Generic Name | H PYLORI (P) KIT |
| Product Code | LYR |
| Date Received | 2011-04-25 |
| Model Number | ICON HP |
| Catalog Number | 395160 |
| Lot Number | 240D11 |
| Device Expiration Date | 2011-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2011-04-25 |