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 2016-05-20 for CORTISOL 11875116122 manufactured by Roche Diagnostics.
[45587479]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[45587480]
The customer stated that they received erroneous results for a total of five patient samples tested for cortisol. The samples were used to compare results from the cortisol assay to results from the cortisol ii assay on an e602 analyzer. The cortisol ii assay is not sold in the united states, nor is it like or similar to a product sold in the united states. It was asked, but it is not known if the cortisol results were reported outside of the laboratory. The customer did not know which results were correct. The customer confirmed that none of the affected samples were collected from patients who used steroids. No error messages were received on the analyzer when testing. The first sample resulted as 25. 78 ug/dl when tested with cortisol and resulted as 13. 56 ug/dl when tested with cortisol ii. The second sample, from a (b)(6) year old male, resulted as 7. 66 ug/dl when tested with cortisol and resulted as 2. 78 ug/dl when tested with cortisol ii. The third sample, collected from a (b)(6) year old female on (b)(6) 2016, resulted as 12. 08 ug/dl when tested with cortisol and resulted as 3. 13 ug/dl when tested with cortisol ii. The fourth sample, collected from a (b)(6) year old female on (b)(6) 2016, resulted as 53. 55 ug/dl when tested with cortisol and resulted as 21. 22 ug/dl when tested with cortisol ii. The fifth sample, collected from a (b)(6) year old male on (b)(6) 2016, resulted as 28. 48 ug/dl when tested with cortisol and resulted as 14. 91 ug/dl when tested with cortisol ii. The patients were not adversely affected. The serial number of the used e602 analyzer was asked for, but not provided.
Patient Sequence No: 1, Text Type: D, B5
[46684432]
A specific root cause could not be determined based on the provided information. Additional information required for the investigation was requested, but not provided. A general reagent could not be seen based on the provided data.
Patient Sequence No: 1, Text Type: N, H10
[48109140]
The customer provided the patient samples for further investigation. For investigations, each sample was tested for cortisol using the cortisol and cortisol ii assays on a cobas 8000 analyzer on 06/01/2016. The samples were tested for cortisol with an lc-ms/ms method. One sample (sample 4) was also tested on a centaur analyzer. All samples were also treated with polyethylene glycol (peg) precipitation and then tested for cortisol and cortisol ii on the cobas 8000 analyzer on 06/01/2016. The first sample resulted as 26. 86 ug/dl when tested for cortisol and resulted as 14. 06 ug/dl for cortisol ii on the cobas 8000 analyzer. The sample was also tested for cortisol using the lc-ms/ms method, resulting as 14. 273 ug/dl. When the sample was treated with peg precipitation, it resulted as 14. 03 ug/dl for cortisol and as 7. 17 ug/dl for cortisol ii on the cobas 8000 analyzer. The second sample resulted as 8. 57 ug/dl when tested for cortisol and resulted as 2. 90 ug/dl for cortisol ii on the cobas 8000 analyzer. The sample was also tested for cortisol using the lc-ms/ms method, resulting as 2. 573 ug/dl. When the sample was treated with peg precipitation, it resulted as 4. 98 ug/dl for cortisol and as 1. 45 ug/dl for cortisol ii on the cobas 8000 analyzer. The third sample resulted as 12. 93 ug/dl when tested for cortisol and resulted as 3. 30 ug/dl for cortisol ii on the cobas 8000 analyzer. The sample was also tested for cortisol using the lc-ms/ms method, resulting as 1. 538 ug/dl. When the sample was treated with peg precipitation, it resulted as 8. 30 ug/dl for cortisol and as 1. 57 ug/dl for cortisol ii on the cobas 8000 analyzer. The fourth sample resulted as 55. 23 ug/dl when tested for cortisol and resulted as 22. 10 ug/dl for cortisol ii on the cobas 8000 analyzer. The sample was also tested for cortisol using the lc-ms/ms method, resulting as 4. 793 ug/dl. The sample was also tested on a centaur analyzer, resulting as 29. 5 ug/dl. When the sample was treated with peg precipitation, it resulted as 36. 39 ug/dl for cortisol and as 10. 60 ug/dl for cortisol ii on the cobas 8000 analyzer. The fifth sample resulted as 29. 97 ug/dl when tested for cortisol and resulted as 15. 06 ug/dl for cortisol ii on the cobas 8000 analyzer. The sample was also tested for cortisol using the lc-ms/ms method, resulting as 15. 673 ug/dl. When the sample was treated with peg precipitation, it resulted as 15. 78 ug/dl for cortisol and as 7. 47 ug/dl for cortisol ii on the cobas 8000 analyzer. No adverse events were alleged. The cobas 8000 analyzer serial number was (b)(4). Cortisol reagent lot number 122033, with an expiration date of april 2017 was used on this analyzer.
Patient Sequence No: 1, Text Type: N, H10
[49064191]
It was stated that the patients were not taking steroid medication. The customer was informed of the investigation results. A specific root cause could not be determined based on the provided information. The investigation results confirmed the customer's results. The differences seen between the cortisol and cortisol ii assays can be explained by the use of a new monoclonal antibody for the cortisol ii assay. The antibody is more specific and shows a lower cross-reactivity than the cortisol polyclonal antibody. The lc-ms/ms method used is very likely standardized differently than the cortisol and cortisol ii assays, which would explain the difference in results to the elecsys and centaur methods. No indication of interference was found.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-00664 |
| MDR Report Key | 5669445 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-05-20 |
| Date of Report | 2016-07-06 |
| Date of Event | 2016-04-15 |
| Date Mfgr Received | 2016-05-10 |
| Date Added to Maude | 2016-05-20 |
| 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 | 2016-05-20 |
| Model Number | NA |
| Catalog Number | 11875116122 |
| Lot Number | 122033 |
| ID Number | NA |
| Device Expiration Date | 2017-04-30 |
| 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 | 2016-05-20 |