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 2016-03-29 for CORTISOL manufactured by Roche Diagnostics.
[41427478]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[41427479]
The customer stated that they performed a comparison study for 30 patient samples tested for cortisol and cortisol ii on an e170 analyzer. The customer was questioning results for one sample in particular, since there was a large result difference between the two assays. Of the provided data, a total of eleven patient samples had erroneous results that were reported outside of the laboratory for cortisol. The cortisol results were reported outside of the laboratory and the results from the cortisol ii assay were believed to be correct. The cortisol ii assay is not sold in the united states, nor is it like or similar to products sold in the united states. The first patient serum sample initially resulted as 13. 7 ug/dl when tested with cortisol. The sample resulted as 8. 95 ug/dl when tested with cortisol ii. The second patient serum sample initially resulted as 10. 3 ug/dl when tested with cortisol on (b)(6) 2016. The sample resulted as 5. 42 ug/dl when tested with cortisol ii. The third patient serum sample initially resulted as 16. 78 ug/dl when tested with cortisol on (b)(6) 2016. The sample resulted as 10. 85 ug/dl when tested with cortisol ii. The fourth patient saliva sample initially resulted as 2. 96 ng/ml when tested with cortisol on (b)(6) 2016. The sample resulted as 0. 54 ug/dl when tested with cortisol ii. The fifth patient saliva sample initially resulted as 6. 73 ng/ml when tested with cortisol on (b)(6) 2016. The sample resulted as 2. 8 ug/dl when tested with cortisol ii. The sixth patient saliva sample initially resulted as 4. 13 ng/ml when tested with cortisol on (b)(6) 2016. The sample resulted as 1. 7 ug/dl when tested with cortisol ii. The seventh patient saliva sample initially resulted as 3. 67 ng/ml when tested with cortisol on (b)(6) 2016. The sample resulted as 1. 78 ug/dl when tested with cortisol ii. The eighth patient saliva sample initially resulted as 5. 67 ng/ml when tested with cortisol on (b)(6) 2016. The sample resulted as 2. 59 ug/dl when tested with cortisol ii. The ninth patient saliva sample initially resulted as 14. 7 ng/ml when tested with cortisol on (b)(6) 2016. The sample resulted as 9. 49 ug/dl when tested with cortisol ii. The tenth patient serum sample initially resulted as 25. 45 ug/dl when tested with cortisol on (b)(6) 2016. The sample resulted as 16. 34 ug/dl when tested with cortisol ii. The eleventh patient serum sample initially resulted as 27. 24 ug/dl when tested with cortisol on (b)(6) 2016. The sample resulted as 17. 61 ug/dl when tested with cortisol ii. The patients were not adversely affected. The e170 analyzer serial number was asked for, but not provided. Investigations have determined that an old cortisol calibration was in use at the time of the event. No general reagent issue was detected.
Patient Sequence No: 1, Text Type: D, B5
[42211588]
Investigations state that with the launch of the cortisol ii assay, the formerly used polyclonal antibody was replaced by a monoclonal antibody, which is more specific and shows a lower cross-reactivity profile. The cortisol ii assay is also standardized against different reference material, which ensures accurate results. This standardization is the reason that a shift in patient results will be observed when switching from cortisol to cortisol ii.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-00368 |
| MDR Report Key | 5532911 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-03-29 |
| Date of Report | 2016-04-07 |
| Date of Event | 2016-02-16 |
| Date Mfgr Received | 2016-03-07 |
| Date Added to Maude | 2016-03-29 |
| 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 | CORTISOL |
| Generic Name | ENZYME IMMUNOASSAY, CORTISOL, SALIVARY |
| Product Code | NHG |
| Date Received | 2016-03-29 |
| Model Number | NA |
| Catalog Number | ASKU |
| 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 | 2016-03-29 |