MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-09-21 for SYNCHRON? ALKALINE PHOSPHATASE (ALP) REAGENT 442670 manufactured by Beckman Coulter, Inc..
[14970149]
A customer contacted beckman coulter inc. (bci) in regards to a synchron alkaline phosphatase (alp) reagent pack that was leaking upon receiving. No injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[15514396]
Service sent a replacement reagent to the customer. No other information is available for this event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2010-00817 |
| MDR Report Key | 1840419 |
| Report Source | 05 |
| Date Received | 2010-09-21 |
| Date of Report | 2010-09-21 |
| Date of Event | 2010-08-24 |
| Date Mfgr Received | 2010-08-25 |
| Device Manufacturer Date | 2010-06-03 |
| Date Added to Maude | 2012-01-06 |
| 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 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 CA 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 | SYNCHRON? ALKALINE PHOSPHATASE (ALP) REAGENT |
| Generic Name | ALKALINE PHOSPHATASE LIQUID REAGENT |
| Product Code | CJE |
| Date Received | 2010-09-21 |
| Model Number | NA |
| Catalog Number | 442670 |
| Lot Number | M005485 |
| Device Expiration Date | 2011-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2010-09-21 |