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? AMYLASE (AMY) REAGENT 442775 manufactured by Beckman Coulter, Inc..
[16641577]
It was discovered in the beckman coulter inc. (bci) warehouse that a synchron amylase reagent pack and array/image calibrator 1 boxes were damaged. No injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[16660898]
Array/immage calibrator 1 product information: catalog numer: 449560, lot number: m904529, manufacturing date: 10/01/2009, expiration date: 12/31/2010, 510(k): k791341. Calibrator. Classification: class ii. Jix, calibrator, multianalyte mixture, panel: clinical chemistry. No other information is available for this event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2010-00814 |
| MDR Report Key | 1840450 |
| Report Source | 05 |
| Date Received | 2010-09-21 |
| Date of Report | 2010-09-21 |
| Date of Event | 2010-06-18 |
| Date Mfgr Received | 2010-06-18 |
| Device Manufacturer Date | 2010-03-11 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNCHRON? AMYLASE (AMY) REAGENT |
| Generic Name | AMYLASE TEST SYSTEM |
| Product Code | JFJ |
| Date Received | 2010-09-21 |
| Model Number | NA |
| Catalog Number | 442775 |
| Lot Number | M001687 |
| Device Expiration Date | 2011-03-31 |
| 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 |