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 2011-09-23 for COULTER AC T 5DIFF CONTROL PLUS 7547198 manufactured by Beckman Coulter, Inc..
[2235228]
The customer reported the coulter ac t 5diff control plus (high level control vial) leaked while lying flat on the counter top. The control had been pierced; how many times is unk. The potential for biohazard exposure with the reported incident was present. In addition, the control was run and the recovery results were elevated. This was noted due to incorrect concentration of cell suspension due to missing diluting fluid (leak). There was no exposure to mucous membranes or open lesions. It is unk if the material safety data sheet (msds) was reviewed, however, it is readily available. No injuries occurred and medical attention was not sought as a result of this event. No reports of death or serious injury, and no affect to operator safety as a result of this event. The product was replaced and all issues were resolved.
Patient Sequence No: 1, Text Type: D, B5
[9356625]
Per labeling, beckman coulter, inc. Urges its customer to comply with all national health and safety standards such as the use of barrier protection. This may include, but it is not limited to, protective eyewear, gloves, and suitable lab attire when operating or maintaining this or any other automated lab analyzer. The coulter ac t 5diff control plus is a hematology quality control material used to monitor the performance of the coulter ac t 5diff hematology analyzers. Pictures of the vial were evaluated. The rubber part in the cap of the high control vial leaked when pierced. Service was not dispatch for this event. Based on available info, the root cause could not be determined. This reportable event was identified during a retrospective review conducted between (b)(6) 2008 and (b)(6) 2010 of complaints for additional reportable events.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-01514 |
| MDR Report Key | 2276810 |
| Report Source | 01,05,06 |
| Date Received | 2011-09-23 |
| Date of Report | 2009-03-31 |
| Date of Event | 2009-03-31 |
| Date Mfgr Received | 2009-03-31 |
| Device Manufacturer Date | 2008-12-01 |
| Date Added to Maude | 2012-06-27 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 BVLD. |
| 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 | 2011-09-23 |
| Model Number | NA |
| Catalog Number | 7547198 |
| Lot Number | 0309 |
| ID Number | NA |
| Device Expiration Date | 2009-05-05 |
| 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 | 11800 SW 147TH AVE. MIAMI FL 33196 US 33196 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-09-23 |