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 2011-10-28 for COULTER ACT 5DIFF RINSE 8547167 manufactured by Beckman Coulter, Inc..
[2226936]
The customer contacted beckman coulter, inc. (bse) to report that their coulter act 5diff rinse is causing erratic white blood cell (wbc) results, increased instrument flagging for wbc, high (wbc) backgrounds, possible interference on red blood cell (rbc) an platelets (plt) results, and precipitant buildup in the reagent containers. The customer reported that erroneous results were possibly reported outside of the laboratory. There was no report of impact to patient treatment associated with this event. It was determined that the root cause of the event was due to contamination of the coulter act 5diff rinse. Contamination of the rinse appears to begin a few days after opening the bottle. The customer reported that quality control (qc) results were within the laboratory's established ranges when running freshly opened coulter act 5diff rinse.
Patient Sequence No: 1, Text Type: D, B5
[9375489]
The root cause of this event is due to contamination of the coulter act 5diff rinse. Product returns were tested and contamination was verified. Bec has opened a capa to further investigate this and other similar reported events. This reportable event was identified during a retrospective review conducted between january 01, 2008 and october 23, 2010 of complaints for additional reportable events.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-02003 |
| MDR Report Key | 2320316 |
| Report Source | 01,05,06 |
| Date Received | 2011-10-28 |
| Date of Report | 2009-01-23 |
| Date of Event | 2009-01-23 |
| Date Mfgr Received | 2009-01-23 |
| Date Added to Maude | 2012-07-10 |
| 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 ACT 5DIFF RINSE |
| Product Code | JCB |
| Date Received | 2011-10-28 |
| Model Number | NA |
| Catalog Number | 8547167 |
| Lot Number | 07302C |
| ID Number | NA |
| 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 | 2011-10-28 |