MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-07-12 for DXH CELL LYSE 628018 manufactured by Beckman Coulter, Inc..
[2122386]
Beckman coulter inc. (bec) has identified internally that there is a potential for erroneous elevated tnc (total nucleated cells) results in body fluid samples in a magnitude corresponding to up to 50 cells/ul for customers using specific lot numbers of dxh cell lyse listed below. High wbc backgrounds at daily checks and body fluids control level i of up to 50 cells/? L may also be seen. 2. Below is a list of other affected lots, their dates of manufacture and expiration: part number, lot number, date of manufacture, expiration date: 628018, 0710003, 11/02/2010, 05/02/2012. 628018, 0711002, 11/16/2010, 05/16/2012. 628018, 0712001, 12/14/2010, 06/14/2012. 628019, 0710002, 10/19/2010, 04/19/2012. 628019, 0710004, 11/01/2010, 05/01/2012. 628019, 0711001, 11/09/2010, 05/09/2012. 628019, 0711003, 11/16/2010, 05/16/2012. 628019, 0712002, 12/13/2010, 06/13/2012. No erroneous results were actually generated, reported or transmitted. There is no death, injury or change to patient treatment associated with this incident.
Patient Sequence No: 1, Text Type: D, B5
[9198784]
Not all customers will experience the daily checks high wbc failure upon startup. Those that fail will not proceed to run specimens, and those that pass will not observe an effect on their wbc count due to the small magnitude of impact by the affected dxh cell lyse. Root cause for the potential erroneous tnc count (and wbc background) is the elevated particle counts detected in multiple lots of dxh cell lyse. Per labeling: - important beckman coulter recommends that a diluent be run as a body fluid sample prior to analysis of body fluid specimens to verify acceptable backgrounds. - the daily checks must pass or be reviewed in order to run specimens.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-00865 |
| MDR Report Key | 2159311 |
| Report Source | 07 |
| Date Received | 2011-07-12 |
| Date of Report | 2011-06-09 |
| Date of Event | 2011-06-09 |
| Date Mfgr Received | 2011-06-09 |
| Device Manufacturer Date | 2010-10-20 |
| Date Added to Maude | 2012-05-22 |
| 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 AVENUE |
| Manufacturer City | MIAMI FL 33196 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33196 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DXH CELL LYSE |
| Generic Name | RED CELL LYSING REAGENT |
| Product Code | GGK |
| Date Received | 2011-07-12 |
| Model Number | NA |
| Catalog Number | 628018 |
| Lot Number | 0710001 |
| ID Number | NA |
| Device Expiration Date | 2012-04-20 |
| Operator | OTHER |
| 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 AVENUE MIAMI FL 33196 US 33196 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-07-12 |