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.
[41544264]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[41544305]
The customer complained of erroneous results for 1 patient tested with both cortisol and cortisol ii. The customer is noticing a difference in the results between the 2 assays and does not know which result is correct. The results for both assays were reported outside of the laboratory. The initial cortisol result was 5. 87 nmol/l. The initial cortisol ii result was 115. 3 nmol/l. These results were run on e602 analyzer with serial number (b)(4). The sample was repeated and the cortisol result was 4. 80 nmol/l. The cortisol ii result was 109. 7. The cortisol result was reported outside of the laboratory as 5 nmol/l and the cortisol ii result was reported outside of the laboratory as 110 nmol/l. These results were run on e602 analyzer with serial number (b)(4). The customer also provided results from a previous sample from this patient obtained on an unknown date and the cortisol result was 9. 0 nmol/l. The cortisol ii result was 114 nmol/l. The customer believes the erroneous results are due to a patient anomaly. No adverse event occurred. The cortisol ii assay is not sold in the united states.
Patient Sequence No: 1, Text Type: D, B5
[43722359]
A specific root cause could not be identified. Additional information for further investigation was requested but was not provided. Based on a review of quality control data, a general reagent issue can be excluded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-00380 |
| MDR Report Key | 5535832 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-03-30 |
| Date of Report | 2016-04-26 |
| Date of Event | 2016-03-12 |
| Date Mfgr Received | 2016-03-15 |
| 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 | 18538001 |
| 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 | 2016-03-30 |