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 2016-03-30 for CORTISOL 11875116122 manufactured by Roche Diagnostics.
[41549857]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[41549858]
The customer questioned results for 1 patient tested for cortisol. The patient typically had low cortisol results with serum samples but on (b)(6) 2016 a urine sample from the patient produced a high cortisol result. The customer sent the patient sample in for further investigation. During the investigation erroneous cortisol results were identified between the e411 analyzer used at the investigation site and a centaur analyzer. The results from the investigation will be provided to the customer. It is not known if erroneous results were reported outside of the laboratory. No adverse event occurred. The e411 analyzer used at the investigation site was hol-3252. The cortisol reagent lot number used at the investigation site was 122033 with an expiration date of 04/2017. The cortisol ii assay is not sold in the united states. A specific root cause could not be identified. A general reagent issue has not been identified based on the quality control data. The results from the e411 analyzer and the centaur analyzer show the same clinical picture which seems to match the clinical picture of the patient. It is not known why the urine sample from (b)(6) 2016 was elevated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2016-00381 |
| MDR Report Key | 5535833 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-03-30 |
| Date of Report | 2016-03-30 |
| Date of Event | 2016-02-20 |
| Date Mfgr Received | 2016-03-17 |
| Date Added to Maude | 2016-03-30 |
| 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 | 2016-03-30 |
| Model Number | NA |
| Catalog Number | 11875116122 |
| Lot Number | 18538006 |
| ID Number | NA |
| Device Expiration Date | 2016-07-31 |
| 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 | 2016-03-30 |