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 2016-08-05 for CORTISOL II manufactured by Roche Diagnostics.
[51342507]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[51342508]
The customer complained of erroneous results for 1 patient tested for cortisol and cortisol ii. The erroneous results were between the cortisol tests run on an e601 analyzer and cortisol ii tests run on an e602 analyzer. The cortisol results were reported outside of the laboratory where they were questioned by the physician since they didn't match the patient's clinical symptoms. This medwatch will cover cortisol ii. Refer to medwatch with patient identifier (b)(6) for information on the cortisol erroneous results. The initial cortisol result from the e601 analyzer was 384. 1 nmol/l. This result was reported outside of the laboratory. The sample was repeated on (b)(6) 2016 and the result was 385. 7 nmol/l. A new sample was obtained and the cortisol result from the e601 analyzer was 258. 4 nmol/l. This result was reported outside of the laboratory. The sample was repeated on (b)(6) 2016 and the result was 272. 1 nmol/l. Both samples were also tested for cortisol ii on the e602 analyzer. The initial sample was repeated twice and the cortisol ii results were 1750 nmol/l with a data flag and 5658 nmol/l. The 2nd sample was repeated twice and the cortisol ii results were 1750 nmol/l with a data flag and 2837 nmol/l. The biochemist is now questioning the difference between the results from cortisol and cortisol ii and wondering if there could be an interference. Other patients were tested and the same behavior was not observed. No adverse event occurred. The e601 analyzer serial number was not provided. The e602 analyzer serial number was not provided. A general reagent issue is not suspected based on the quality control data provided. The sample and reagent handling at the customer site seems to be in accordance with specifications. A specific root cause could not be identified. Additional information was requested for investigation but was not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2016-01114 |
| MDR Report Key | 5850916 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-08-05 |
| Date of Report | 2016-08-05 |
| Date of Event | 2016-07-11 |
| Date Mfgr Received | 2016-07-18 |
| Date Added to Maude | 2016-08-05 |
| 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 II |
| Generic Name | FLUOROMETRIC, CORTISOL |
| Product Code | JFT |
| Date Received | 2016-08-05 |
| Model Number | NA |
| Catalog Number | ASKU |
| Lot Number | 189893 |
| ID Number | NA |
| 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 | 2016-08-05 |