MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2011-07-30 for ACCESS OSTASE IMMUNOENZYMETRIC ASSAY OSTASE CALIBRATOR 37305 manufactured by Beckman Coulter Inc..
[2040594]
Beckman coulter inc. (bec) (b)(4) reported receiving three (3) damaged ostase calibrator, which leaked. Beckman coulter (b)(4) is not questioning any patient results. No injury or exposure to the fluid was reported.
Patient Sequence No: 1, Text Type: D, B5
[9279371]
An investigation of the damaged ostase qc and calibrator vials was conducted at bec (b)(4). The investigation 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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2011-02584 |
| MDR Report Key | 2184842 |
| Report Source | 01,05,06 |
| Date Received | 2011-07-30 |
| Date of Report | 2011-06-29 |
| Date of Event | 2011-06-29 |
| Date Mfgr Received | 2011-06-29 |
| Device Manufacturer Date | 2011-02-01 |
| Date Added to Maude | 2012-06-19 |
| 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 | NO |
| Previous Use Code | 3 |
| Removal Correction Number | Z-2605-6-2011 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCESS OSTASE IMMUNOENZYMETRIC ASSAY |
| Generic Name | CALIBRATOR |
| Product Code | JIS |
| Date Received | 2011-07-30 |
| Model Number | OSTASE CALIBRATOR |
| Catalog Number | 37305 |
| Lot Number | 114260 |
| ID Number | N/A |
| Device Expiration Date | 2011-11-30 |
| Operator | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 | 2011-07-30 |