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 2012-01-19 for FP, BCI TC GIEMSA STAIN 7547201 manufactured by Beckman Coulter, Inc..
[2569931]
A customer contacted beckman coulter inc. , (bec) and reported that the intensity of the cell coloration of peripheral blood smears diminishes rapidly causing the inability to accurately identify white blood count (wbc) cell populations on stained smears when using lot numbers 0626169 and 0626170 of the fp, bci tc giemsa stain on board the coulter lh 750 slide stainer instrument. Based on available information, the customer has filed a (b)(4) report with the (b)(4) competent authorities. There was no death, injury or change to patient treatment associated with this event and there is a remote probability that the hazard will cause medically reversible or transient health consequences.
Patient Sequence No: 1, Text Type: D, B5
[9583136]
The giemsa stain is used in combination with other romanowsky stains to stain whole blood smears prepared on glass microscope slides in the lh slidestainer. The are no claims in the giemsa stain instructions for use (ifu) for stain stability on board the instrument. Per labeling, the coulter lh 750 slide stainer operator's guide states: beckman coulter provides no performance claims for this instrument. Information is supplied to the customers as reference material only and (performance) is not guaranteed by beckman coulter. The issue is currently under investigation by the supplier. The root cause is unknown. Giemsa stain, lot number 0626169. Information for giemsa lot number 0626170 is provided below: manufactured date: 03/16/2011; expiration date: 05/16/2011. Lh750 slide stainer information: brand name: coulter lh 750 slide stainer. Common device name: slide stainer, automated. Product code: kpa. Product code name: slide stainer, automated. Device class; class i; classification panel: pathology. C. F. R. Section: 864. 3800- automated slide stainer. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2012-00186 |
| MDR Report Key | 2421961 |
| Report Source | 01,05,06 |
| Date Received | 2012-01-19 |
| Date of Report | 2011-12-21 |
| Date of Event | 2010-01-01 |
| Date Mfgr Received | 2011-12-21 |
| Device Manufacturer Date | 2012-04-18 |
| Date Added to Maude | 2012-08-07 |
| 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 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149614941 |
| Manufacturer G1 | BECKMAN CULTER INC. |
| Manufacturer Street | 11800 SW 147TH AVENUE |
| Manufacturer City | MIAMI FL 33196 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33196 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FP, BCI TC GIEMSA STAIN |
| Generic Name | GIEMSA STAIN |
| Product Code | HYF |
| Date Received | 2012-01-19 |
| Model Number | NA |
| Catalog Number | 7547201 |
| Lot Number | 0626169, 0626170 |
| ID Number | NA |
| Device Expiration Date | 2012-04-18 |
| 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 AVENUE MIAMI FL 33196 US 33196 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-01-19 |