MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-10-26 for SYNCHRON DRUG CALIBRATOR 2 469630 manufactured by Beckman Coulter, Inc..
[17407459]
Customer reported to beckman coulter, inc. (bec) that they received an empty vial of drug calibrator 3. According to customer, the reagent appeared to have leaked out from the vial. Customer reported that there was no crack on the vial. There was no report of erroneous results generated. There was no report of any adverse event or injury requiring medical intervention or patient treatment.
Patient Sequence No: 1, Text Type: D, B5
[17815987]
Bec is filing this mdr because drug calibrator 3 reagent contains materials of human or animal origin and should be considered as potentially capable of transmitting infectious diseases. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-06414 |
| MDR Report Key | 2308912 |
| Report Source | 05,06 |
| Date Received | 2011-10-26 |
| Date of Report | 2011-09-27 |
| Date of Event | 2011-09-27 |
| Date Mfgr Received | 2011-09-27 |
| Device Manufacturer Date | 2011-04-25 |
| Date Added to Maude | 2012-07-10 |
| 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. DUNG NGUYEN |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNCHRON DRUG CALIBRATOR 2 |
| Generic Name | CALIBRATORS, DRUG SPECIFIC |
| Product Code | DLJ |
| Date Received | 2011-10-26 |
| Model Number | DRUG CALIBRATOR 2 |
| Catalog Number | 469630 |
| Lot Number | NA |
| Device Expiration Date | 2013-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 250 S. KRAMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-10-26 |