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 2011-10-07 for COULTER AC.T 5DIFF RINSE 8547167 manufactured by Beckman Coulter, Inc..
[2294151]
Customer reported erroneous test results were obtained for red blood cell (rbc) count, hematocrit (hct) and platelet (plt) count for two pts. There were instrument generated flags with the test results. Erroneous flagged results were not reported out of the lab. The customer reran the samples and the above mentioned parameters recovered higher. Reruns for both samples were considered correct. The coulter act 5diff rinse was found to be contaminated and was replaced. No reports of death or serious injury, and no affect to pt treatment as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[9373439]
On (b)(6) 2008, the coulter ac. T 5diff rinse was replaced by the customer and a replacement bottle was provided. Product was returned on (b)(6) 2008. Testing was performed and the product was confirmed to be contaminated. Field service was requested to decontaminate the instrument and check system dilution performance. The problem was resolved with the replacement of the coulter ac. T 5diff rinse reagent. As of (b)(4), 2008, there were no further reported events of erroneous results from this account. This reportable event was identified during a retrospective review conducted between (b)(4) 2008 and (b)(4) 2010 of complaints for add'l reportable events.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-01597 |
| MDR Report Key | 2320146 |
| Report Source | 01,05,06 |
| Date Received | 2011-10-07 |
| Date of Report | 2008-06-25 |
| Date of Event | 2008-06-11 |
| Date Mfgr Received | 2008-06-25 |
| Device Manufacturer Date | 2007-12-01 |
| Date Added to Maude | 2012-06-29 |
| 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 |
| 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 AVE. |
| Manufacturer City | MIAMI FL 33196 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33196 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COULTER AC.T 5DIFF RINSE |
| Product Code | JCB |
| Date Received | 2011-10-07 |
| Model Number | NA |
| Catalog Number | 8547167 |
| Lot Number | 06702C |
| ID Number | NA |
| Device Expiration Date | 2008-12-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 11800 SW 147TH AVE. MIAMI FL 33196 US 33196 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-10-07 |