MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-03-23 for ACCESS? FOLATE CALIBRATORS A14207 manufactured by Beckman Coulter, Inc..
[2595160]
The customer reported the calibrator vials cracked and leaked contents involving access folate calibrators. The customer noticed the vials were cracked and leaking during thawing of the folate calibrators. The customer stated there were "small puddles" under each vial of the calibrator. The customer contained all leakage. There was no evidence of damage to the kit box. The customer stated there was no exposure to the leak contents and cleaned up the leak per the laboratory procedure in place. There was no report of injury or adverse effect associated with this event. Beckman coulter customer technical support (cts) sent the customer the replacement folate calibrator kit.
Patient Sequence No: 1, Text Type: D, B5
[9752774]
There is no indication the device was returned for evaluation. The cause of the event is unknown. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2012-00897 |
| MDR Report Key | 2502652 |
| Report Source | 05,06 |
| Date Received | 2012-03-23 |
| Date of Report | 2012-02-29 |
| Date of Event | 2012-02-29 |
| Date Mfgr Received | 2012-02-29 |
| Device Manufacturer Date | 2011-06-01 |
| Date Added to Maude | 2012-09-04 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 7149614941 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCESS? FOLATE CALIBRATORS |
| Generic Name | ACID, FOLIC, RADIOIMMUNOASSAY |
| Product Code | CGN |
| Date Received | 2012-03-23 |
| Model Number | NA |
| Catalog Number | A14207 |
| Lot Number | 112788 |
| ID Number | NA |
| Device Expiration Date | 2012-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2012-03-23 |