MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-07-07 for SYNCHRON? ALKALINE PHOSPHOTASE (ALP) 476821 manufactured by Beckman Coulter Inc..
[18414628]
A customer contacted beckman coulter inc. (bci) regarding a broken alkaline phosphotase (alp) cartridge that was found while removing the reagent from the unicel dxc 800 pro synchron clinical system. The customer did not know if the cartridge had any signs of damage prior to loading onto the instrument. The customer noticed that the volume status reduced sooner than it was supposed to which prompted the customer to remove the cartridge. No injury was reported and no false patient results were generated.
Patient Sequence No: 1, Text Type: D, B5
[18738620]
Per customer, they did not need replacement. Service was not requested.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-02885 |
| MDR Report Key | 2152785 |
| Report Source | 06 |
| Date Received | 2011-07-07 |
| Date of Report | 2011-06-07 |
| Date of Event | 2011-06-07 |
| Date Mfgr Received | 2011-06-07 |
| Device Manufacturer Date | 2011-01-26 |
| Date Added to Maude | 2012-03-20 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| 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 | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92821 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNCHRON? ALKALINE PHOSPHOTASE (ALP) |
| Generic Name | ALKALINE PHOSPHOTASE |
| Product Code | CJE |
| Date Received | 2011-07-07 |
| Model Number | NA |
| Catalog Number | 476821 |
| Lot Number | M101617 |
| Device Expiration Date | 2012-07-31 |
| 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 | 250 S. KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-07-07 |