MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-06-18 for ACT 5DIFF RINSE 8547167 manufactured by Beckman Coulter.
[21293131]
The customer reported to beckman coulter (bec) an ongoing problem with white blood count (wbc) vote-outs on the coulter ac t 5diff cp analyzer. Per conversation with the customer, the issue was occurring on controls and patient samples. The instrument printouts for this occurrence were not provided for review. No erroneous results were reported out of the laboratory. There was no death, injury or effect to patient treatment.
Patient Sequence No: 1, Text Type: D, B5
[21488079]
A beckman coulter field service engineer (fse) assisted the customer over the phone on (b)(4) 2013. The customer indicated that there was visible white residue observed in the reagent bottle, lot number 13002c00357. The fse had the customer replace rinse reagent to one of a new lot and prime the new reagent. Additionally, the system was cleaned with 50/50 bleach/water solution and back flush was performed. The customer also performed an extended cleaning procedure. The fse followed up the following day, (b)(4) 2013, to verify the operation of the instrument. Per conversation with the customer on (b)(4) 2013, there have been no further issues since changing to a new lot. Failure mode was attributed to contaminated act 5 diff rinse reagent.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2013-01158 |
| MDR Report Key | 3176028 |
| Report Source | 05,06 |
| Date Received | 2013-06-18 |
| Date of Report | 2013-05-21 |
| Date of Event | 2013-05-21 |
| Date Mfgr Received | 2013-05-21 |
| Device Manufacturer Date | 2012-12-27 |
| Date Added to Maude | 2013-09-12 |
| 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 CULTER |
| 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 | ACT 5DIFF RINSE |
| Generic Name | DETERGENT |
| Product Code | JCB |
| Date Received | 2013-06-18 |
| Model Number | NA |
| Catalog Number | 8547167 |
| Lot Number | 13002C00357 |
| ID Number | NA |
| Device Expiration Date | 2013-12-27 |
| Operator | HEALTH PROFESSIONAL |
| Device Eval'ed by Mfgr | N |
| 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 | 2013-06-18 |