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 2017-04-17 for ELECSYS CORTISOL II 06687733190 manufactured by Roche Diagnostics.
[72877689]
(b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[72877690]
The customer received questionable elecsys cortisol ii results for three patient samples compared to the results from a beckman coulter (clia method). The samples were retested by the other method as the initial results did not match the clinical condition of the patients. Patient 1: the initial result on (b)(6) 2017 was 31. 19 ug/dl. The result by clia on (b)(6) 2017 was 20. 5 ug/dl. The repeat result by the roche method in another laboratory was 33. 66 ug/dl. Patient 2: (female, (b)(6)): the initial result on (b)(6) 2017 was 28. 01 ug/dl. The result by clia on (b)(6) 2017 was 11. 1 ug/dl. The repeat result by the roche method in another laboratory was 29. 58 ug/dl. Patient 3: (female, (b)(6)): the initial result on (b)(6) 2017 was 33. 21 ug/dl. The result by clia on (b)(6) 2017 was 24. 2 ug/dl. The repeat result by the roche method in another laboratory was 38. 25 ug/dl. The results by the roche method were released out of laboratory to the physician. There was no allegation of an adverse event. The customer used cobas 6000 serial number (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[76652550]
Additional information was provided that the physician did not agree with the results from beckman coulter (clia method).
Patient Sequence No: 1, Text Type: N, H10
[117968198]
One sample from patient 2 was submitted for investigation and the customer's result by the roche method was confirmed. Information was clarified that the physician had stated the result by the clia method was more consistent with clinical profile of the patient.
Patient Sequence No: 1, Text Type: N, H10
[132583183]
A specific root cause could not be determined as insufficient sample material remained for further investigation. A general reagent issue was not suspected based on the qc data and the fact that the customer's result was confirmed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-00793 |
| MDR Report Key | 6496816 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-04-17 |
| Date of Report | 2017-07-26 |
| Date of Event | 2017-03-14 |
| Date Mfgr Received | 2017-03-31 |
| Date Added to Maude | 2017-04-17 |
| 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 | 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 | 2017-04-17 |
| Model Number | NA |
| Catalog Number | 06687733190 |
| Lot Number | 161251 |
| 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 | 2017-04-17 |