MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-02-25 for HEMOCCULT ICT HEMOCCULT ICT TEST DEVICE 395069 manufactured by Beckman Coulter Inc.
[22051269]
The test was on fecal sample. Investigation by rapids qc did not confirm the customer complaint. Service explained the importance of proper buffer addition technique to the customer. The customer noted that they may not have performed the test as per the product instructions.
Patient Sequence No: 1, Text Type: N, H10
[22092921]
A customer reported to beckman coulter inc. , (bci) to report receiving negative test results with colon cancer patients that were tested with hemoccult ict. The result was not reported out of the laboratory; hence, no injury or death has been reported in connection with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2518658-2011-00004 |
| MDR Report Key | 2001634 |
| Report Source | 05 |
| Date Received | 2011-02-25 |
| Date of Report | 2010-10-08 |
| Date of Event | 2010-10-08 |
| Date Mfgr Received | 2010-10-08 |
| Device Manufacturer Date | 2009-08-01 |
| 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 | 3 |
| 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 | HEMOCCULT ICT |
| Generic Name | HEMOCCULT ICT TEST DEVICE |
| Product Code | KHE |
| Date Received | 2011-02-25 |
| Model Number | HEMOCCULT ICT TEST DEVICE |
| Catalog Number | 395069 |
| Lot Number | M002693 |
| ID Number | N/A |
| Device Expiration Date | 2011-08-31 |
| 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 | 2011-02-25 |