MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-12-07 for 4C-ES CELL CONTROL 7547187 manufactured by Beckman Coulter, Inc..
[2460359]
On (b)(6) 2011, customer reported a leak of control material because the 4c control vial caps were received broken for the act diff2 instrument. The event happened in october but was recently reported because of a shortage of control material. No injuries were reported and no erroneous patient results were generated. Customer was sent a replacement 4c es control pack. Service was not dispatched for this event.
Patient Sequence No: 1, Text Type: D, B5
[9570661]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-02583 |
| MDR Report Key | 2362421 |
| Report Source | 05,06 |
| Date Received | 2011-12-07 |
| Date of Report | 2011-11-15 |
| Date of Event | 2011-10-17 |
| Date Mfgr Received | 2011-11-15 |
| Device Manufacturer Date | 2011-09-02 |
| Date Added to Maude | 2012-07-23 |
| 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. DUNG NGUYEN |
| Manufacturer Street | 250 SOUTH KRAEMER BOULEVARD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149614941 |
| Manufacturer G1 | BECKMAN COULTER, INC. |
| Manufacturer Street | 11800 SW 147TH AVENUE |
| Manufacturer City | MIAMI FL 33196 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33196 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 4C-ES CELL CONTROL |
| Generic Name | MIXTURE, HEMATOLOGY QUALITY CONTROL |
| Product Code | JPK |
| Date Received | 2011-12-07 |
| Model Number | 4C-ES |
| Catalog Number | 7547187 |
| Lot Number | 1685283K/ 089800 |
| Device Expiration Date | 2012-01-02 |
| 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 | 250 SOUTH KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-12-07 |