MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-12-15 for COULTER AC.T 5DIFF CONTROL PLUS AC.T 5DIFF CP 7547198 manufactured by Beckman Coulter, Inc..
[2449025]
Customer called to report that a shipment of the coulter ac. T 5diff control plus, lot #1111, received on (b)(6) 2011, was at room temperature upon arrival and that some of the vials' contents had leaked inside of the box. Customer was wearing gloves, a lab coat and goggles at the time of the incident. There was no exposure to mucous membranes or open wounds reported and medical attention was not sought. Customer stated that there did not seem to be physical damage to either the box or the control vials and could not establish how the contents had spilled; however, the leak was contained within the box. Per the submitter, the package was ordered to be shipped via (b)(4) "second day" delivery, as per standard protocol. The product is packaged so that product temperature is within specifications within this time frame. However, the facility was closed when (b)(4) attempted to deliver the package on friday, (b)(6) 2011; therefore, the carrier made a second attempt to deliver the package on monday, (b)(6) 2011. By this time, the product had been in transit for five days, and the product was stored outside acceptable temperatures. Once the package was redelivered, the storage conditions were exceeded. The customer technical specialist (cts) verified the "ship to" address and submitted a replacement order.
Patient Sequence No: 1, Text Type: D, B5
[9576376]
The root cause of the leak is unknown; however, the leak was contained within the box. Customer was sent a replacement shipment and has not called back to report any further issues. (b)(4). Shipment not returned for investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-02663 |
| MDR Report Key | 2378066 |
| Report Source | 05,06 |
| Date Received | 2011-12-15 |
| Date of Report | 2011-11-16 |
| Date of Event | 2011-11-16 |
| Date Mfgr Received | 2011-11-16 |
| Device Manufacturer Date | 2011-08-15 |
| Date Added to Maude | 2012-07-24 |
| 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 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 928216232 |
| Manufacturer Country | US |
| Manufacturer Postal | 928216232 |
| Manufacturer Phone | 7149614941 |
| Manufacturer G1 | BECKMAN COULTER, INC. |
| Manufacturer Street | 11800 SW 147TH AVE. |
| 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 AC.T 5DIFF CONTROL PLUS |
| Generic Name | MIXTURE, HEMATOLOGY QUALITY CONTROL |
| Product Code | JPK |
| Date Received | 2011-12-15 |
| Model Number | AC.T 5DIFF CP |
| Catalog Number | 7547198 |
| Lot Number | 361111 / 371111 / 381111 |
| Device Expiration Date | 2012-01-05 |
| 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 | 250 S. KRAEMER BLVD. BREA CA 92821623 US 92821 6232 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-12-15 |