MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-08-17 for SYNCHRON? SYSTEMS ALCOHOL (ETOH) REAGENT 474947 manufactured by Beckman Coulter, Inc..
[19040468]
Sample collection and centrifugation information was not supplied. The customer's calibration and quality control data showed no errors. Bec hotline personnel suggested to the customer to run a di water blank as a test sample to confirm high results. A blank test sample resulting 0. 007 g/dl or higher would indicate a problem with the reagent. A new lot of reagent seemed to resolve the problem. Bec sent the customer environmental caps to ensure reagent integrity.
Patient Sequence No: 1, Text Type: N, H10
[19103777]
A customer contacted beckman coulter, inc. (bec) to report obtaining erroneously high ethanol (etoh) results for two patients. The results were generated on a unicel dxc 600i synchron access clinical system, used in conjunction with synchron systems alcohol (etoh) reagent (lot m011697). Rerun of patient samples using a different lot of synchron systems alcohol (etoh) reagent (lot m101930) yielded lower results. The elevated etoh results were reported out of the lab but were amended with rerun results. The customer confirmed that there was no effect on patient treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2050012-2011-03778 |
| MDR Report Key | 2215522 |
| Report Source | 05,06 |
| Date Received | 2011-08-17 |
| Date of Report | 2011-07-08 |
| Date of Event | 2011-07-02 |
| Date Mfgr Received | 2011-07-08 |
| Device Manufacturer Date | 2010-12-15 |
| Date Added to Maude | 2012-05-09 |
| 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. 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? SYSTEMS ALCOHOL (ETOH) REAGENT |
| Generic Name | ALCOHOL TEST SYSTEM |
| Product Code | DMT |
| Date Received | 2011-08-17 |
| Model Number | NA |
| Catalog Number | 474947 |
| Lot Number | M011697 |
| ID Number | NA |
| Device Expiration Date | 2011-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Eval'ed by Mfgr | Y |
| 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 | 2011-08-17 |