MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-12-07 for SYNCHRON CX4/CX5 CLINICAL CHEMISTRY ANALYZER REAGENT 442640 manufactured by Beckman Coulter, Inc..
[2505030]
Customer reported to beckman coulter, inc. (bec) that glucose (lot # m110149) reagent cartridge leaked from the bottom seam. Customer reported that erroneous results were not generated. There was no report of any adverse event or injury requiring medical intervention or patient treatment.
Patient Sequence No: 1, Text Type: D, B5
[9564764]
Glucose reagent contains material of animal origin and should be considered potentially infectious. This report is one of three reports related to three events that occurred on the same day. This report is related to mdr#2050012-2011-08192 and mdr#2050012-2011-08203. Bec identifier for this complaint is (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-08202 |
| MDR Report Key | 2361378 |
| Report Source | 05,06 |
| Date Received | 2011-12-07 |
| Date of Report | 2011-11-07 |
| Date of Event | 2011-11-07 |
| Date Mfgr Received | 2011-11-07 |
| Device Manufacturer Date | 2011-10-12 |
| Date Added to Maude | 2011-12-19 |
| 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 CX4/CX5 CLINICAL CHEMISTRY ANALYZER REAGENT |
| Generic Name | HEXOKINASE, GLUCOSE |
| Product Code | CKA |
| Date Received | 2011-12-07 |
| Catalog Number | 442640 |
| Lot Number | M110149 |
| Device Expiration Date | 2013-10-31 |
| 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. KRAMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-12-07 |