MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-02-23 for ACTIVE? NON-EXTRACTION IGF-1 ELISA DSL-10-2800 manufactured by Beckman Coulter, Inc..
[15504939]
A customer contacted beckman coulter inc. (bci) in regards to receiving one dsl-10-2800 non extraction igf-1 elisa kit that contained an empty vial of the igf-1 antibody enzyme conjugate concentrate. The entire content of 0. 3 ml had leaked out of the vial. There was no evidence that the kit box had been damaged. The customer did not report effect to patients or end users in association with this event.
Patient Sequence No: 1, Text Type: D, B5
[15731234]
The kit was discarded along with the leaking vial and the customer requested replacement which is being arranged. No root cause was determined for this event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2011-00491 |
| MDR Report Key | 1999690 |
| Report Source | 06 |
| Date Received | 2011-02-23 |
| Date of Report | 2011-01-24 |
| Date of Event | 2011-01-24 |
| Date Mfgr Received | 2011-01-24 |
| Date Added to Maude | 2012-02-08 |
| 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 | RL |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACTIVE? NON-EXTRACTION IGF-1 ELISA |
| Generic Name | HUMAN GROWTH HORMONE TEST |
| Product Code | CFL |
| Date Received | 2011-02-23 |
| Model Number | NA |
| Catalog Number | DSL-10-2800 |
| Lot Number | 091031 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2011-02-23 |