MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2011-11-18 for DSL 7800 ACTIVE CORTISOL DSL-10-2000 manufactured by Beckman Coulter, Inc..
[2312305]
Beckman coulter, inc. Quality assurance reported elevated cortisol results, for pt serum samples, involving dsl 7800 active cortisol. The elevated results were not released out of the laboratory. There has been no report of pt injury or change in pt treatment associated with the lot in question.
Patient Sequence No: 1, Text Type: D, B5
[9565509]
Investigation was conducted to study bias for the dsl (diagnostics systems laboratories) cortisol eia (enzyme immunoassay). The assay was not anchored properly and drifted over time. The product has been discontinued. This reportable event was identified during a retrospective review of product complaints conducted from (b)(6) 2008 through (b)(6) 2010 for additional reportable events.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628193-2011-00005 |
| MDR Report Key | 2351738 |
| Report Source | 05,07 |
| Date Received | 2011-11-18 |
| Date of Report | 2009-07-09 |
| Date of Event | 2009-07-09 |
| Date Mfgr Received | 2009-07-09 |
| Device Manufacturer Date | 2009-02-01 |
| Date Added to Maude | 2012-07-17 |
| 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 | 445 MEDICAL CENTER BLVD |
| Manufacturer City | WEBSTER TX 77598 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 77598 |
| 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 | 2011-11-18 |
| 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 | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 445 MEDICAL CENTER BLVD WEBSTER TX 77598 US 77598 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-11-18 |