MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2011-10-03 for CALIBRATOR FOR PLATELET COUNTING S-CAL CAL KIT 624519 manufactured by Beckman Coulter Inc..
[2238710]
.
Patient Sequence No: 1, Text Type: D, B5
[2257722]
The beckman coulter inc (bec) (b)(4) representative reported that blood adhered to an s-cal calibrator kit. The employees were wearing personal protective equipment (ppe) consisting of lab coat, gloves, and facemasks when handling the reagent. No injuries occurred, medical attention was not sought, and no exposure to mucous membranes or open wounds was reported. Patient treatment was not impacted due to the reagent component. Review of pictures received showed the presence of multiple smudges on the out package of the reagent; however, the source of the smudges was undetermined. Service was not dispatched and the root cause is unknown.
Patient Sequence No: 1, Text Type: D, B5
[9412932]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[9412933]
(b)(4)
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-01609 |
| MDR Report Key | 2271292 |
| Report Source | 01,07 |
| Date Received | 2011-10-03 |
| Date of Report | 2011-09-02 |
| Date of Event | 2011-09-02 |
| Date Mfgr Received | 2011-09-02 |
| Device Manufacturer Date | 2011-08-11 |
| Date Added to Maude | 2012-06-28 |
| 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 BVLD |
| 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 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CALIBRATOR FOR PLATELET COUNTING |
| Generic Name | CALIBRATOR FOR PLATELET COUNTING |
| Product Code | KRY |
| Date Received | 2011-10-03 |
| Model Number | S-CAL CAL KIT |
| Catalog Number | 624519 |
| Lot Number | 1158178F |
| ID Number | N/A |
| Device Expiration Date | 2011-09-22 |
| Operator | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Device Availability | Y |
| 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 | 2011-10-03 |