MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-07-30 for UNICEL? DXC 800 SYNCHRON? SYSTEM A11812 manufactured by Beckman Coulter, Inc..
[2044773]
The customer reported that on (b)(6) 2011, an erroneous false phencyclidine (pcp) result was generated on a unicel dxc 800 synchron system for one emergency room patient sample. The sample also tested positive for benzodiazepine (bnzg). The pcp and bngz results were reported outside of the laboratory prior to the confirmatory alternative method testing (such as gas chromatography/mass spectrometry (gc/ms) testing) as is recommended by beckman coulter inc. 's pcp chemistry information sheet. The patient was transferred to another facility because they were in significant distress. The patient expired shortly after hospital transfer due to a drug overdose of methylenedioxypyrovalerone (mdpv), a synthetically manipulated derivative product from the parent drug, cathinone. The customer indicated that the patient death was not attributed to the false positive pcp result or beckman coulter inc. Instrument performance. The results of the patient's autopsy indicated a negative pcp result and positive result for bnzg when tested via gc/ms. The pcp reagent is not a beckman coulter inc. Manufactured product. The instrument's pcp and bnzg quality control and calibration results were within the customer's established specifications prior to and after this event. No other drugs of abuse analytes tested with this sample were questioned, and no other patient results were questioned or rerun during this time.
Patient Sequence No: 1, Text Type: D, B5
[9279014]
Mdpv is not listed in the cross reactivity table in the beckman coulter inc. Pcp chemistry information sheet labeling as this is a new drug and has never been tested before by the reagent vendor for cross reactivity to the pcp reagent kit. This event was communicated to the pcp reagent vendor. The vendor performed analysis of the mdpv drug against the pcp reagent kit. Quantitative results were obtained which demonstrate a positive pcp result in the presence of the mdpv drug. These results will be added to the synchron pcp labeling.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-03794 |
| MDR Report Key | 2184901 |
| Report Source | 05,06 |
| Date Received | 2011-07-30 |
| Date of Report | 2011-06-30 |
| Date of Event | 2011-04-15 |
| Date Mfgr Received | 2011-06-30 |
| Device Manufacturer Date | 2009-07-06 |
| Date Added to Maude | 2012-05-24 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNICEL? DXC 800 SYNCHRON? SYSTEM |
| Generic Name | ANALYZER, CHEMISTRY |
| Product Code | LCM |
| Date Received | 2011-07-30 |
| Model Number | NA |
| Catalog Number | A11812 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| 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 KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-07-30 |