MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-07-19 for DRI? ECSTASY ENZYME IMMUNOASSAY A39935 manufactured by Beckman Coulter, Inc..
[2105804]
A customer reported to beckman coulter, inc. (bec) of obtaining erroneous positive result for ecstasy for one (1) patient. The result was generated on the ecstasy calibration cut-off value was 146. 4 ma/min and the patient result was 168. 6 ma/min. The sample was confirmed negative by a recommended confirmatory method prior to reporting. The confirmatory method was a quantitative test and the result was negative when compared to a standard of 200ng/ml. This was a sample specific event. No other samples were in question. No other drug screen analytes run with this sample were in question. No instrument malfunction was determined. Patient treatment was not affected in regard to this event.
Patient Sequence No: 1, Text Type: D, B5
[9142250]
The sample was urine. Microgenics dri ecstasy assay is an approved for use oem user-defined product and manufactured by microgenics. The root cause appears to be a sample specific drug interference response.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-03222 |
| MDR Report Key | 2168349 |
| Report Source | 05,06 |
| Date Received | 2011-07-19 |
| Date of Report | 2011-06-14 |
| Date of Event | 2011-06-08 |
| Date Mfgr Received | 2011-06-14 |
| Date Added to Maude | 2012-04-04 |
| 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 | MICROGENICS CORPORATION |
| Manufacturer Street | 46360 FREMONT BOULEVARD |
| Manufacturer City | FREMONT CA 94538 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94538 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRI? ECSTASY ENZYME IMMUNOASSAY |
| Generic Name | AMPHETAMINE TEST SYSTEM |
| Product Code | DKZ |
| Date Received | 2011-07-19 |
| Model Number | NA |
| Catalog Number | A39935 |
| Lot Number | 5921 |
| ID Number | NA |
| 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 | 2011-07-19 |