MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2011-02-14 for ACCESS? OSTASE CALIBRATOR 37305 manufactured by Beckman Coulter, Inc..
[20623997]
Beckman coulter (b)(6) reported a damaged access ostase calibrator vial, which leaked the content. There was no report of any impact to patients or end users in association to this event.
Patient Sequence No: 1, Text Type: D, B5
[20710517]
An investigation of damaged ostase qc and calibrator vials was conducted at bci. It was determined that the glass vials are not compatible to freezing at -70? C.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2011-00198 |
| MDR Report Key | 1988264 |
| Report Source | 01,07 |
| Date Received | 2011-02-14 |
| Date of Report | 2010-11-17 |
| Date of Event | 2010-11-17 |
| Date Mfgr Received | 2011-11-17 |
| Date Added to Maude | 2012-02-06 |
| 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 BOULEVARD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| Manufacturer G1 | BECKMAN COULTER, INC. |
| Manufacturer Street | 1000 LAKE HAZELTINE DRIVE |
| Manufacturer City | CHASKA MN 55318 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55318 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCESS? OSTASE CALIBRATOR |
| Generic Name | OSTASE CALIBRATOR |
| Product Code | JIS |
| Date Received | 2011-02-14 |
| Model Number | NA |
| Catalog Number | 37305 |
| Lot Number | 015210 |
| Operator | HEALTH PROFESSIONAL |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 1000 LAKE HAZELTINE DRIVE CHASKA MN 55318 US 55318 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-02-14 |