MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-06-17 for ACT 5DIFF RINSE 8547167 manufactured by Beckman Coulter.
[3550822]
The customer reported to beckman coulter (bec) that the coulter ac t 5diff cp analyzer was giving white blood count (wbc) *, voting out, and giving no numerical wbc results on multiple patient samples. The customer indicated that patient #1? Patient # 4 samples were drawn on (b)(6) 2013 and were analyzed the same day in the hospital laboratory (reference laboratory). The hospital's results were considered correct. The patient samples were run four days later ((b)(6) 2013) on the act 5diff cp instrument, which recovered low complete blood count/differential (cbc/diff) results with and without the instrument generated messages on each parameter. The erroneous results were not reported outside of the laboratory. There was no death, injury or effect to patient treatment. Patient # 6 results obtained from this analyzer on (b)(6) 2013 is documented in mdr 1061932-2013-01170. Two (2) mdrs are being submitted for the erroneous cbc/diff results obtained at this customer site: 1061932-2013-01169, 1061932-2013-01170.
Patient Sequence No: 1, Text Type: D, B5
[10852361]
A beckman coulter field service engineer (fse) was dispatched to the customer site. The fse inspected and replaced aperture, replaced o-rings, and white blood cell (wbc) bath. Upon further inspection, the fse observed mucus like substance on an old electrode that had just been removed. The fse ran several samples and the mucus substance appeared on the wbc electrode again. The fse discovered the mucus substance was in the rinse reagent bottle. Per phone conversation with the customer, the subject reagent had been in use for 11 days when the issue was observed. No results were reported outside of the laboratory; samples were sent out for analysis. The fse decontaminated the instrument and replaced the rinse reagent with a new bottle, expiration date 03/20/2014, and verified the instrument's operation. Failure mode was attributed to the mucus like substance present in the rinse reagent bottle. It is unknown how the reagent got contaminated. The analyzer generated messages for some parameters which alerted the customer to review the results.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2013-01169 |
| MDR Report Key | 3173806 |
| Report Source | 05,06 |
| Date Received | 2013-06-17 |
| Date of Report | 2013-05-20 |
| Date of Event | 2013-05-20 |
| Date Mfgr Received | 2013-05-20 |
| Device Manufacturer Date | 2012-12-27 |
| Date Added to Maude | 2013-09-11 |
| 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 | 2013-06-17 |
| Model Number | NA |
| Catalog Number | 8547167 |
| Lot Number | 13002C00424 |
| ID Number | NA |
| Device Expiration Date | 2013-12-27 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2013-06-17 |