MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2011-09-30 for COULTER AC-T 5DIFF CONTROL PLUS 7547198 manufactured by Beckman Coulter, Inc..
[19187130]
The customer reported that the coulter ac-t 5diff control plus low control is leaking during the mixing process. The tube leaks at the center of the cap after 10 to 12 pierces from the coulter ac-t 5diff instrument probe. The customer states this happened "on every lot of control. " according to the customer the tube was pierced correctly by the analyzer in the middle of the rubber section of the cap. The coulter ac-t 5diff control plus consists of human erythrocytes, simulated leukocytes, and mammalian platelets in a plasma-like fluid and is considered a potential biohazard. The customer was wearing proper ppe (personal protective equipment) including lab coat and gloves when handling the product. There was no reported exposure of material to open lesions or mucous membranes. The operator did not seek medical attention.
Patient Sequence No: 1, Text Type: D, B5
[19447208]
This reportable event was identified during a retrospective review conducted for the period between (b)(6) 2008 and (b)(6) 2010 of complaints for additional reportable events. Per product labeling, open vial use claim was twenty times (20) within thirty-five (35) days. Labeling also indicates "note: do not use a mechanical mixer" when preparing the control vial for use. The customer stored and warmed up their quality control tubes in an upright position. The laboratory subsequently introduced new handling procedures and noted that the incidence of leaking has been "greatly reduced. " the root cause is unknown though may have been related to user handling procedures.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-01553 |
| MDR Report Key | 2281686 |
| Report Source | 01,05,06 |
| Date Received | 2011-09-30 |
| Date of Report | 2009-08-25 |
| Date of Event | 2009-08-24 |
| Date Mfgr Received | 2009-08-25 |
| Date Added to Maude | 2012-06-28 |
| 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 NORA ZEROUNIAN |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| 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 |
| Product Code | JPK |
| Date Received | 2011-09-30 |
| Model Number | NA |
| Catalog Number | 7547198 |
| Lot Number | 0709 |
| ID Number | NA |
| 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 AVE. MIAMI FL 33196 US 33196 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-09-30 |