MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2012-01-13 for ACCESS? OSTASE CALIBRATORS 37305 manufactured by Beckman Coulter, Inc..
[2432836]
The affiliate reported a beckman coulter associate alleged a blood-like substance adhered to the exterior of the device packaging involving access ostase calibrators and access ostase qc. This is report number one of two. There was no report of injury or adverse effect associated with this event.
Patient Sequence No: 1, Text Type: D, B5
[9534637]
There is no indication the device was returned for evaluation. This report is related to mdr 2122870-2012-00079.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2012-00068 |
| MDR Report Key | 2414464 |
| Report Source | 01,07 |
| Date Received | 2012-01-13 |
| Date of Report | 2011-12-13 |
| Date of Event | 2011-12-13 |
| Date Mfgr Received | 2011-12-13 |
| Device Manufacturer Date | 2011-08-01 |
| Date Added to Maude | 2012-03-20 |
| 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. 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 COULTER, INC. |
| Manufacturer Street | 1000 LAKE HAZELTINE DRIVE |
| Manufacturer City | CHASKA CA 55318 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55318 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCESS? OSTASE CALIBRATORS |
| Generic Name | ELECTROPHORETIC SEPARATION, ALKALINE PHOSPHATASE ISOENZYMES |
| Product Code | CIN |
| Date Received | 2012-01-13 |
| Model Number | NA |
| Catalog Number | 37305 |
| Lot Number | 122325 |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 1000 LAKE HAZELTINE DRIVE CHASKA MN 55318 US 55318 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-01-13 |