MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2011-03-11 for ALKALINE PHOSPHATASE (ALP) 442670 manufactured by Beckman Coulter Inc..
[1913364]
A customer contacted beckman coulter inc. , (bci) and reported that alp reagent kept on giving level sensor error. Customer checked wedge and the alp cartridge leaked on the instrument. No injury was reported in connection with this event.
Patient Sequence No: 1, Text Type: D, B5
[9098623]
Replacement reagent was sent.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-00696 |
| MDR Report Key | 2016307 |
| Report Source | 01,05 |
| Date Received | 2011-03-11 |
| Date of Report | 2011-02-11 |
| Date of Event | 2011-02-07 |
| Date Mfgr Received | 2011-02-11 |
| Device Manufacturer Date | 2010-09-07 |
| Date Added to Maude | 2012-01-30 |
| 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 | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92821 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALKALINE PHOSPHATASE (ALP) |
| Generic Name | ALKALINE PHOSPHATASE (ALP) |
| Product Code | CJE |
| Date Received | 2011-03-11 |
| Model Number | NA |
| Catalog Number | 442670 |
| Lot Number | T008188 |
| 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 92822800 US 92822 8000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-03-11 |