MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-08-19 for TRUCOLOR WRIGHT'S GIEMSA STAIN KIT 7547178 manufactured by Beckman Coulter, Inc..
[2157566]
Customer reported the presence of yeast cells with the differential results for two pts after using blood smear slides that were stained for analysis with the lh slide stainer and trucolor wright's giemsa stain kit. The presence of yeast cells with the differential results were reported out of the laboratory for the two pts. The customer determined the source of the yeast cells to be the trucolor wright's giemsa stain kit. The customer reported that in addition to the two pts that were reported with yeast cells, four to five add'l samples were seen with yeast cells on the blood smear slide prepared with the same lh slide stainer and trucolor wright's giemsa stain kit. No reports of death or serious injury, and no affect to pt treatment as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[9346954]
The customer determined the trucolor wright's giemsa stain kit was contaminated by performing the following actions: the customer placed the same lot# of trucolor wright's giemsa stain kit on two lh slide stainer instruments. The yeast cells were present on the manual smears from both of these instruments. The customer also cultured the rinse water from the slide stainer instruments and performed gram stain of the buffer, both were negative. The customer decontaminated the slide stainer and replaced the stain with the contaminated lot# and the yeast cells persisted. The customer switched stain lot# and the yeast cells were no longer present. The product was not returned for eval. Microbial contamination of the stain has not been confirmed by beckman coulter inc. The suspect stain lot number cannot be returned from the customer due to dept of transportation regulations. Root cause is unk. The customer replaced the stain with different stain reagent lot# and no other reports of yeast contamination have been received. A review for similar events was conducted. There have been no other reports of yeast contamination in slide stain reagents from 2005 to 2010. This reportable event was identified during a retrospective review conducted between 01/01/2008 and 10/23/2010 of complaints for add'l reportable events.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-01206 |
| MDR Report Key | 2256782 |
| Report Source | 05,06 |
| Date Received | 2011-08-19 |
| Date of Report | 2010-04-23 |
| Date of Event | 2010-04-22 |
| Date Mfgr Received | 2010-04-23 |
| Date Added to Maude | 2012-06-21 |
| 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 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 | TRUCOLOR WRIGHT'S GIEMSA STAIN KIT |
| Product Code | KQC |
| Date Received | 2011-08-19 |
| Model Number | NA |
| Catalog Number | 7547178 |
| Lot Number | 609681 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2011-08-19 |