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 2014-04-25 for CORTISOL 06687733190 manufactured by Roche Diagnostics.
[4356159]
The customer alleged they received questionable cortisol results for one patient on their cobas 8000 e602 module, serial number (b)(4). The patient's initial cortisol result was 2. 90 ug/l. The sample was sent to another laboratory and tested in the roche method. The repeat result was 4 ng/ml. The sample was then sent to another laboratory and tested with a beckman-coulter method and the result was 154 ng/ml. The customer stated the roche results were reported outside the laboratory. The patient was not adversely affected by this event.
Patient Sequence No: 1, Text Type: D, B5
[11748792]
The customer returned one patient sample for investigation. The sample was tested on a cobas e602 using cortisol retention reagent lot number 174778. The customer's sample result was reproduced.
Patient Sequence No: 1, Text Type: N, H10
[11775529]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[12076514]
Further investigation of the patient sample indicated an interference was present in the patient sample. Interference due to extremely high titers of antibodies to analyte-specific antibodies can occur. The low cortisol value reported by the customer was confirmed. This interference is documented in product labeling.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2014-03075 |
| MDR Report Key | 3773403 |
| Report Source | 01,05,06 |
| Date Received | 2014-04-25 |
| Date of Report | 2014-07-08 |
| Date of Event | 2014-04-01 |
| Date Mfgr Received | 2014-04-11 |
| Date Added to Maude | 2014-04-25 |
| 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 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 | 2014-04-25 |
| Model Number | NA |
| Catalog Number | 06687733190 |
| Lot Number | 174778 |
| 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 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-04-25 |