MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2013-07-19 for CORTISOL 11875116122 manufactured by Roche Diagnostics.
[3683592]
The customer alleged they received questionable cortisol and acth results on their e-module for one patient. The customer provided data for one discrepant cortisol result. The patient's initial cortisol result was 24. 3 ug/dl and it was reported outside the laboratory. On (b)(6) 2013, the sample was repeated and the result was 27. 9 ug/dl. The sample was sent to another laboratory for testing. The exact date of the test was requested but not provided. It was assumed by the customer that the second laboratory tested the sample using a centaur analyzer. This repeat result was 9. 9 ug/dl. There had been no reports of any adverse events. The cortisol reagent lot number was 171646 and the expiration date was 06/29/2014.
Patient Sequence No: 1, Text Type: D, B5
[10947605]
This event occured in (b)(6) no information was provided on the specific part number involved in this event.
Patient Sequence No: 1, Text Type: N, H10
[11194482]
Patient sample was returned for investigation. An interference to streptavidin was identified in the sample. This interference is covered in product labeling.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2013-04387 |
| MDR Report Key | 3237666 |
| Report Source | 01,05,06 |
| Date Received | 2013-07-19 |
| Date of Report | 2013-10-03 |
| Date of Event | 2013-07-02 |
| Date Mfgr Received | 2013-07-08 |
| Date Added to Maude | 2013-07-19 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | NA JENNIFER WOLFGRAM |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175217008 |
| 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 | 2013-07-19 |
| Model Number | NA |
| Catalog Number | 11875116122 |
| Lot Number | 171646 |
| ID Number | NA |
| Device Expiration Date | 2014-06-29 |
| 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 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-07-19 |