MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-11-18 for COULTER ACT 5DIFF CONTROL PLUS 7547198 manufactured by Beckman Coulter, Inc..
[2357492]
On (b)(6) 2011 customer reported that some of their control vials, mainly their high level vial of the act 5 diff control, was found to be leaking as part of a delivery to the lab. However, based on further information from the customer the vials were found to be leaking after removing the vials from the refrigerator a few days later. Customer stated that there was no visual damage to the vials. Replacement vials were sent to the customer. No injuries were reported and no erroneous patient results were generated.
Patient Sequence No: 1, Text Type: D, B5
[9484953]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-02252 |
| MDR Report Key | 2341585 |
| Report Source | 05,06 |
| Date Received | 2011-11-18 |
| Date of Report | 2011-10-26 |
| Date of Event | 2011-10-26 |
| Date Mfgr Received | 2011-10-26 |
| Device Manufacturer Date | 2011-08-15 |
| Date Added to Maude | 2012-07-17 |
| 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 | COULTER ACT 5DIFF CONTROL PLUS |
| Generic Name | MIXTURE, HEMATOLOGY QUALITY CONTROL |
| Product Code | JPK |
| Date Received | 2011-11-18 |
| Catalog Number | 7547198 |
| Lot Number | 1111 |
| Device Expiration Date | 2012-01-05 |
| 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 | 11800 SW 147TH AVENUE MIAMI FL 33196 US 33196 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-11-18 |