MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2011-12-16 for IMMUNOPREP REAGENT SYSTEM 7546999 manufactured by Beckman Coulter, Inc..
[2444173]
Customer reported to beckman coulter, inc. (bec) that liquid leaked from a bottle of the immunoprep reagent system. Customer reported that the bottle was not damaged. Customer reported that the leak was from the inner seal of the reagent bottle. Customer reported that the inside of the box was also dirty. The immunoprep reagent kit was not use on any analyzer. There was no report of patient results affected. There was no report of any adverse event or injury requiring medical intervention or patient treatment.
Patient Sequence No: 1, Text Type: D, B5
[9559504]
Bec identifier for this complaint is (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-02685 |
| MDR Report Key | 2379472 |
| Report Source | 01,07 |
| Date Received | 2011-12-16 |
| Date of Report | 2011-11-17 |
| Date of Event | 2011-11-17 |
| Date Mfgr Received | 2011-11-17 |
| Device Manufacturer Date | 2011-08-10 |
| Date Added to Maude | 2012-07-25 |
| 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 | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMUNOPREP REAGENT SYSTEM |
| Generic Name | PRODUCTS, RED-CELL LYSING PRODUCTS |
| Product Code | GGK |
| Date Received | 2011-12-16 |
| Catalog Number | 7546999 |
| Lot Number | 1099059K |
| Device Expiration Date | 2012-11-01 |
| Operator | OTHER |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 | 2011-12-16 |