MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-07-21 for DSL-10-2000 ACTIVE? CORTISOL ENZYME IMMUNOASSAY (EIA) KIT manufactured by Beckman Coulter Inc..
[1084015]
During an internal testing conducted by beckman coulter inc. (bci), it was reported that false high cortisol values were generated by the dsl-10-2000 active cortisol enzyme immunoassay (eia) kit. Beckman coulter has confirmed that the following lot numbers: 04195, 04195a, 04195b, 04195d, 04195e, 04195f, 09266a, 09266, 04126a, 04126, 03066a, 03066, 01036, 716217, 716218, 800408, 800409, 800410, 890929 and 990168 of active cortisol elisa calibrators over estimate the expected dose values for patient serum samples due to a shift in the assigned calibrator values. An example for lot 990168 which yielded values significantly above (2-5x) other products. All kits with affected lots resulted in overestimation of cortisol dose. Patient results were not generated in this event since the event was discovered in-house and no patient samples were tested at the time. There was no affect to patient treatment as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[8434750]
Root cause of the shift in the calibration of the assigned standard values is currently under investigation. A malfunction will be assumed for the purpose of this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628193-2009-00001 |
| MDR Report Key | 1416817 |
| Report Source | 05 |
| Date Received | 2009-07-21 |
| Date of Report | 2009-07-21 |
| Date of Event | 2009-07-09 |
| Date Mfgr Received | 2009-07-09 |
| Date Added to Maude | 2010-03-16 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. NORA ZEROUNIAN |
| Manufacturer Street | 200 S. KRAEMER BOULEVARD |
| Manufacturer City | BREA CA 928228000 |
| Manufacturer Country | US |
| Manufacturer Postal | 928228000 |
| 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 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DSL-10-2000 ACTIVE? CORTISOL ENZYME IMMUNOASSAY (EIA) KIT |
| Generic Name | ACTIVE? CORTISOL EIA, 96 WELLS |
| Product Code | CGR |
| Date Received | 2009-07-21 |
| Model Number | NA |
| Catalog Number | DSL-10-2000 |
| Operator | HEALTH PROFESSIONAL |
| Device Eval'ed by Mfgr | N |
| 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 | 2009-07-21 |