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 2012-01-30 for SYNCHRON? CLINICAL CHEMISTRY ANALYZER REAGENT 442820 manufactured by Beckman Coulter, Inc..
[2557664]
The affiliate reported the customer alleged fluid leaked at the base of one reagent cartridge involving synchron urea. The customer stated the leak started when the cap was removed from the cartridge. The customer properly discarded the leaking cartridge. No patient results were reported to be affected. There was no exposure to open lesions or mucus membranes. There was no report of injury or adverse effect associated with this event.
Patient Sequence No: 1, Text Type: D, B5
[9594030]
There is no indication the device was returned for evaluation. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2012-00301 |
| MDR Report Key | 2432426 |
| Report Source | 01,05,06 |
| Date Received | 2012-01-30 |
| Date of Report | 2012-01-03 |
| Date of Event | 2012-01-02 |
| Date Mfgr Received | 2012-01-03 |
| Device Manufacturer Date | 2011-08-24 |
| Date Added to Maude | 2012-08-09 |
| 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 | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92821 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNCHRON? CLINICAL CHEMISTRY ANALYZER REAGENT |
| Generic Name | UREASE AND GLUTAMIC DEHYDROGENASE, UREA NITROGEN |
| Product Code | CKA |
| Date Received | 2012-01-30 |
| Model Number | NA |
| Catalog Number | 442820 |
| Lot Number | T108098 |
| ID Number | NA |
| Device Expiration Date | 2013-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 250 S. KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-01-30 |