MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2011-10-07 for DSL 7800 ACTIVE CORTISOL DSL-10-2000 manufactured by Beckman Coulter, Inc..
[2297786]
A beckman coulter representative, within quality control, reported elevated cortisol results for true samples and controls involving dsl 7800 active cortisol. The elevated results did not correlate with alternate methodologies. There was no patient impact. There was no patient injury or change in patient treatment associated with this event.
Patient Sequence No: 1, Text Type: D, B5
[9374984]
Investigation confirmed dsl-10-2000 produced results 2 to 4 times higher compared to other test analyses. This reportable event was identified during a retrospective review of product complaints conducted from january 01, 2008 through october 23, 2010 for additional reportable events.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628193-2011-00003 |
| MDR Report Key | 2320067 |
| Report Source | 05,07 |
| Date Received | 2011-10-07 |
| Date of Report | 2009-06-09 |
| Date of Event | 2009-06-09 |
| Date Mfgr Received | 2009-06-09 |
| Device Manufacturer Date | 2009-02-01 |
| Date Added to Maude | 2012-06-29 |
| 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 | 1000 LAKE HAZELTINE DRIVE |
| Manufacturer City | CHASKA MN 55318 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55318 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Removal Correction Number | 2050012-07/22/2009-006C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DSL 7800 ACTIVE CORTISOL |
| Product Code | CGR |
| Date Received | 2011-10-07 |
| Model Number | NA |
| Catalog Number | DSL-10-2000 |
| Lot Number | 990168 |
| ID Number | NA |
| Device Expiration Date | 2009-09-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 1000 LAKE HAZELTINE DRIVE CHASKA MN 55318 US 55318 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-10-07 |