MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2011-02-07 for ACCESS? HLH CALIBRATORS 33515 manufactured by Beckman Coulter, Inc..
[1734582]
A customer contacted beckman coulter, inc (bci) in regards to an access hlh calibrator kit in which the s4 vial was cracked upon receiving. The contents had leaked and dried encrusting the outside the vial. The customer did not report effect to patients or end users in association to this event.
Patient Sequence No: 1, Text Type: D, B5
[8934234]
There was no evidence that the kit box itself had been damaged. The lh calibrator kit was discarded along with the cracked vial. Service was not dispatched for this event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2011-00201 |
| MDR Report Key | 1980816 |
| Report Source | 01,06 |
| Date Received | 2011-02-07 |
| Date of Report | 2010-12-31 |
| Date of Event | 2010-12-31 |
| Date Mfgr Received | 2010-12-31 |
| Date Added to Maude | 2012-01-19 |
| 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 | 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 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCESS? HLH CALIBRATORS |
| Generic Name | LUTEINIZING HORMORNE |
| Product Code | CEP |
| Date Received | 2011-02-07 |
| Model Number | NA |
| Catalog Number | 33515 |
| Lot Number | 008546 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2011-02-07 |