MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2019-04-01 for ELECSYS CORTISOL II 07027150190 manufactured by Roche Diagnostics.
[140618537]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[140618538]
The initial reporter stated that they received erroneous results for two samples from the same patient tested with elecsys cortisol ii on a cobas 8000 e 801 module. It was asked, but it is unknown if any erroneous results were reported outside of the laboratory. The first sample (plasma) resulted with an initial cortisol value of > 63. 4 ug/dl. The sample was automatically diluted times 10 and repeated, resulting with a value of 18. 6 ug/dl. The sample was automatically diluted times 2 and repeated, resulting with a value around 29 ug/dl. The sample was manually diluted times 2 and repeated, resulting with a value around 29 ug/dl. The sample was then repeated without dilution, resulting with a value of > 63. 4 ug/dl. The second sample (serum) resulted with an initial cortisol value of > 63. 4 ug/dl. The sample was diluted times 2 and repeated, resulting with a value of around 20 ug/dl. The sample was also diluted times 10 and times 20, resulting with values around 18 ug/dl. The customer believed the correct value for the patient is around 18 ug/dl. No adverse events were alleged to have occurred with the patient. The investigation did not identify a product problem.? The cause of the event could not be determined.? A general reagent issue could be excluded based on the provided quality control data which was within expectations.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2019-01270 |
| MDR Report Key | 8469676 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-04-01 |
| Date of Report | 2019-04-01 |
| Date of Event | 2019-03-13 |
| Date Mfgr Received | 2019-03-13 |
| Date Added to Maude | 2019-04-01 |
| 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 | 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 | ELECSYS CORTISOL II |
| Generic Name | FLUOROMETRIC, CORTISOL |
| Product Code | JFT |
| Date Received | 2019-04-01 |
| Model Number | NA |
| Catalog Number | 07027150190 |
| Lot Number | 353299 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2019-04-01 |