MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-09-28 for SYNCHRON? ALKALINE PHOSPHATASE REAGENT ALP 442670 manufactured by Beckman Coulter, Inc..
[2304343]
A customer received a synchron alkaline phosphatase (alp) reagent kit that had leaked and stained the box yellow. One of the cartridges (s/n 3mr) in the kit gave a reagent low error when loaded on the instrument. There was no exposure to uncovered wounds or mucous membranes. No injury was reported. Msds was not reviewed, but the facility has an exposure control plan. The operator did not seek medical attention and there was no effect to patient or user.
Patient Sequence No: 1, Text Type: D, B5
[9350580]
There was no obvious source of leak on the cartridge and the box was dry. Service was not dispatched for this event. A replacement kit was sent to the customer. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-05433 |
| MDR Report Key | 2268267 |
| Report Source | 05,06 |
| Date Received | 2011-09-28 |
| Date of Report | 2011-09-02 |
| Date of Event | 2011-09-02 |
| Date Mfgr Received | 2011-09-02 |
| Device Manufacturer Date | 2011-02-02 |
| Date Added to Maude | 2012-06-08 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. NORA ZEROUNIAN |
| Manufacturer Street | 250 S. KRAEMER BLVD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| 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 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNCHRON? ALKALINE PHOSPHATASE REAGENT |
| Generic Name | ALKALINE PHOSPHATASE TEST SYSTEM |
| Product Code | CJE |
| Date Received | 2011-09-28 |
| Model Number | ALP |
| Catalog Number | 442670 |
| Lot Number | NA |
| Device Expiration Date | 2012-08-31 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2011-09-28 |