MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-06-15 for 4C PLUS COULTER CELL CONTROL 7547114 manufactured by Beckman Coulter, Inc..
[2123190]
Customer reported a potential biohazard event of a leak from the stopper of a normal control vial when using the 4c plus coulter cell control and a coulter ac-t diff 2 analyzer. The customer was wearing personal protective equipment when the event occurred on (b)(6) 2008. There was no exposure to mucous membrane or open lesion. No reports of death or serious injury, and no affect to operator safety as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[9243874]
Customer reported one of three levels of the 4c plus coulter cell control as leaking. The 4c plus coulter cell control vial that was reported as leaking was not evaluated. A field service engineer did evaluate the coulter ac-t diff 2 analyzer and aligned the piercing mechanism. Root cause could have been associated with a misalignment of the piercing mechanism on the coulter ac-t diff 2 analyzer. However, a definitive root cause was not determined. 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 | 1061932-2011-00570 |
| MDR Report Key | 2175323 |
| Report Source | 05,06 |
| Date Received | 2011-06-15 |
| Date of Report | 2008-10-15 |
| Date of Event | 2008-10-15 |
| Date Mfgr Received | 2008-10-15 |
| Date Added to Maude | 2012-04-23 |
| 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 | 4C PLUS COULTER CELL CONTROL |
| Product Code | JPK |
| Date Received | 2011-06-15 |
| Model Number | NA |
| Catalog Number | 7547114 |
| Lot Number | 076800 |
| ID Number | NA |
| Device Expiration Date | 2008-11-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2011-06-15 |