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 2012-08-24 for CORTISOL 11875116122 manufactured by Roche Diagnostics.
[2796457]
The customer discovered questionable cortisol results for one patient when the results from other analyzers were compared. The result received from a cobas e411 analyzer and repeated on a cobas e601 was 60 nmol/l which was below the reference range. They repeated the measurements again and the result was 66 nmol/l. The sample was frozen and later measured on axsym and the result was within the reference range. No specific data was provided. The same sample was then measured in another laboratory on an analytical e module analyzer and the result was 51 nmol/l. The result from an architect analyzer was 234. 5 nmol/l. Another sample from this patient was analyzed by ria method and the result was within the reference range. No specific data was provided. No information was provided to determine if any erroneous results were reported outside the laboratory or if the patient was adversely affected. The serial numbers of the involved analyzers were not provided. The investigation was unable to determine a specific root cause. As the sample was measured in different labs with different analyzers, a general reagent or analyzer issue was not suspected.
Patient Sequence No: 1, Text Type: D, B5
[10033000]
It was unknown if the initial reporter sent report to the fda. This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2012-04305 |
| MDR Report Key | 2713544 |
| Report Source | 01,05,06 |
| Date Received | 2012-08-24 |
| Date of Report | 2012-08-24 |
| Date of Event | 2012-08-01 |
| Date Mfgr Received | 2012-08-01 |
| Date Added to Maude | 2012-08-24 |
| 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 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 | 2012-08-24 |
| Model Number | NA |
| Catalog Number | 11875116122 |
| Lot Number | ASKU |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2012-08-24 |