MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-03-02 for ACCESS OSTASE ASSAY N/A 37309 manufactured by Beckman Coulter Inc..
[1716306]
Beckman coulter (b)(4) reported one damaged ostase qc vial, which leaked leak. One qc box was impacted by damaged qc vial. The customer did not report affect to patients or end users in association to this event.
Patient Sequence No: 1, Text Type: D, B5
[9100864]
An investigation of the damaged ostase qc and calibrator vials was conducted at bci (b)(4) determined the glass vials are not compatible to freezing at -70 degrees celsius. A 100% inspection is conducted when the vial labeling process is performed.
Patient Sequence No: 1, Text Type: N, H10
[21672270]
.
Patient Sequence No: 1, Text Type: D, B5
[21924896]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2011-00515 |
| MDR Report Key | 2004982 |
| Report Source | 06 |
| Date Received | 2011-03-02 |
| Date of Report | 2011-02-01 |
| Date of Event | 2011-02-01 |
| Date Mfgr Received | 2011-02-01 |
| Date Added to Maude | 2012-02-07 |
| 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 | 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 | Z-2605-6-2011 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCESS OSTASE ASSAY |
| Generic Name | LECTROPHORETIC SEPARATION, ALKALINE PHOSPHATASE ISOENZYMES |
| Product Code | CIN |
| Date Received | 2011-03-02 |
| Model Number | N/A |
| Catalog Number | 37309 |
| Lot Number | 021285 |
| ID Number | N/A |
| 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 | 1000 LAKE HAZELTINE DRIVE CHASKA MN 55318 US 55318 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-03-02 |