MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-09-17 for COULTER ACT 5 DIFF WBC LYSE 8547170 manufactured by Beckman Coulter.
[4840795]
The customer reported high cv (coefficient of variation) was obtained for the white blood cell (wbc) parameter when using the coulter act 5 diff cap pierce (cp). The customer performed troubleshooting by completing extended cleaning. The problem was not resolved and a beckman coulter field service engineer (fse) was sent to the customer's facility to evaluate the analyzer. The fse identified crystals / precipitate / particles in the act 5diff wbc lyse reagent. There was no report of erroneous test results reported out of the laboratory for this event. There was no death, injury or affect to user or patient treatment.
Patient Sequence No: 1, Text Type: D, B5
[12283637]
On (b)(4) 2014, the field service engineer (fse) evaluated the instrument and identified the act5diff wbc lyse reagent showed crystal particles. The fse flushed the system and installed a fresh bottle of wbc lyse reagent and verified it was clear of any precipitate. The fse performed verification and validation, all within specification. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2014-02354 |
| MDR Report Key | 4097384 |
| Report Source | 05,06 |
| Date Received | 2014-09-17 |
| Date of Report | 2014-08-21 |
| Date of Event | 2014-08-21 |
| Date Mfgr Received | 2014-08-21 |
| Device Manufacturer Date | 2014-01-22 |
| Date Added to Maude | 2014-09-29 |
| 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. 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 COULTER |
| 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 | COULTER ACT 5 DIFF WBC LYSE |
| Generic Name | PRODUCTS, RED-CELL LYSING PRODUCTS |
| Product Code | GGK |
| Date Received | 2014-09-17 |
| Model Number | NA |
| Catalog Number | 8547170 |
| Lot Number | 19002B |
| Device Expiration Date | 2015-01-22 |
| Operator | HEALTH PROFESSIONAL |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER |
| Manufacturer Address | 250 S. KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-09-17 |