MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-10-25 for SYNCHRON SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CRPH) REAGENT C-REACTIVE PROTEIN KIT 465131 manufactured by Beckman Coulter, Inc..
[2249460]
Customer reported to beckman coulter, inc. (bec) that they received a damaged c-reactive protein (crp) reagent pack. Customer reported that they observed the leak while in the process of loading the reagent on the system. Customer reported that they did not load the reagent on board. Customer reported that no erroneous results were generated or reported. There was no report of any adverse event or injury requiring medical intervention or patient treatment.
Patient Sequence No: 1, Text Type: D, B5
[9316483]
Bec is filing this mdr because crp reagent contains materials of animal origin and should be considered as potentially capable of transmitting infectious diseases. Bec identifier for this complaint is (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-06298 |
| MDR Report Key | 2306591 |
| Report Source | 05,06 |
| Date Received | 2011-10-25 |
| Date of Report | 2011-09-26 |
| Date of Event | 2011-09-26 |
| Date Mfgr Received | 2011-09-26 |
| Device Manufacturer Date | 2011-01-21 |
| Date Added to Maude | 2012-07-10 |
| 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 | 7149613634 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNCHRON SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CRPH) REAGENT |
| Generic Name | CARDIAC C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL |
| Product Code | NQD |
| Date Received | 2011-10-25 |
| Model Number | C-REACTIVE PROTEIN KIT |
| Catalog Number | 465131 |
| Lot Number | M012260 |
| Device Expiration Date | 2013-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 250 S. KRAMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-10-25 |