MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-06-17 for CORTISOL 11875116160 manufactured by Roche Diagnostics.
[2056560]
The customer stated they were receiving questionable results for cortisol on their modular analytics e-module (serial number (b)(4)). The customer provided data for four samples with discrepant results reported outside the laboratory. Repeat testing was performed on the same e-module and issued as a corrected report. The first patient's initial cortisol result was 57. 92 ug/dl. The repeat result was 11. 50 ug/dl. The second patient's initial cortisol result was 4. 26 ug/dl. The repeat result was 15. 38 ug/dl. The third patient's initial cortisol result was 63. 44 ug/dl accompanied by a data flag. The analyzer automatically repeated the sample and the result was 117. 3 ug/dl. The second repeat result was 15. 69 ug/dl. The fourth patient's initial result was 56. 86 ug/dl. The repeat result was 11. 83 ug/dl. The customer was not aware of any adverse affects to the patients as a result of this event. The customer refused a service visit. The customer resolved the issue by troubleshooting the analyzer. They performed liquid flow cleaning three times and measuring cell preparation twenty times.
Patient Sequence No: 1, Text Type: D, B5
[9016039]
The other assays related to this event are reported in medwatch reports patient identifiers: (b)(6).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2011-03316 |
| MDR Report Key | 2132643 |
| Report Source | 05,06 |
| Date Received | 2011-06-17 |
| Date of Report | 2011-06-17 |
| Date of Event | 2011-05-23 |
| Date Mfgr Received | 2011-05-25 |
| Date Added to Maude | 2011-06-17 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | NA RAE ANN FARROW |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175213194 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68305 |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CORTISOL |
| Generic Name | ENZYME IMMUNOASSAY, CORTISOL, SALIVARY |
| Product Code | NHG |
| Date Received | 2011-06-17 |
| Model Number | NA |
| Catalog Number | 11875116160 |
| Lot Number | 15879802 |
| ID Number | NA |
| Device Expiration Date | 2011-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-06-17 |