MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional report with the FDA on 2016-02-04 for CORTISOL 11875116160 manufactured by Roche Diagnostics.
[37439432]
Patient Sequence No: 1, Text Type: N, H10
[37439433]
The customer complained of erroneous high results for 1 patient sample tested for cortisol. The erroneous results were reported outside of the laboratory. The customer is requesting information on interferences for the cortisol assay. The initial cortisol result had a flag and the result was diluted. The diluted result was 166. 2 ug/dl. The sample was sent out to a reference laboratory using liquid chromatography-mass spectrometry and the result was 47. 6 ug/dl. No adverse event occurred. The modular e 170 serial number was (b)(4). Preventive maintenance was performed on (b)(6) 2016.
Patient Sequence No: 1, Text Type: D, B5
[39375905]
A specific root cause could not be identified. Additional information for further investigation was requested but was not provided. The liquid chromatography-mass spectrometry result of 47. 6 ug/dl suggests a patient sample with high cortisol concentrations. The high result of 166. 2 ug/dl from the modular e 170 analyzer confirms this. Based on a review of the patient medications, none were identified as interfering with the assay, however, it is not known how the specific mix of medications could affect results from the cortisol assay.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-00101 |
| MDR Report Key | 5409533 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2016-02-04 |
| Date of Report | 2016-03-01 |
| Date of Event | 2016-01-11 |
| Date Mfgr Received | 2016-01-19 |
| Date Added to Maude | 2016-02-04 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | NA MICHAEL LESLIE |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175214343 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68305 |
| Manufacturer Country | GM |
| 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 | 2016-02-04 |
| Model Number | NA |
| Catalog Number | 11875116160 |
| Lot Number | ASKU |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-04 |