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 2016-07-22 for CORTISOL manufactured by Roche Diagnostics.
[50186831]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[50186832]
The customer stated that they received erroneous results for one patient sample tested for free triiodothyronine (ft3), free thyroxine (ft4), and cortisol on an e601 analyzer. The patient's ft4 value was said to be implausible and was not fitting the patient's clinical history. The patient had no clinical symptoms of hyperthyreosis. The patient's cortisol result was said to be implausible. There were no error messages on the analyzer. It was stated that the patient sample behaved strangely with almost all applied elecsys assays. This medwatch will cover the cortisol assay. Please refer to the medwatch with (b)(6) for information related to the ft3 assay and the medwatch with (b)(6) for information related to ft4. The patient sample initially resulted as 16. 54 pmol/l for ft3, > 100 pmol/l for ft4, and 1610 nmol/l for cortisol. The initial values were reported outside of the laboratory. The doctor did not trust the initial values, so he requested repeat analysis of the sample with assays from a different manufacturer. The sample was repeated on a siemens vista analyzer, resulting as 7. 56 pmol/l for ft3, > 100 pmol/l for ft4, and 1441 nmol/l for cortisol. The customer also stated that the ft4 value was unchanged after blocking the "heterophile ak". The patient was not adversely affected. The e601 analyzer serial number was (b)(4). The patient sample was provided for investigation. During investigation of the sample, the ft3, ft4, and cortisol values obtained by the customer could be confirmed. Further investigations of the sample did not detect any interfering factors within the sample. For the differences seen in the ft3 results, different assays from different vendors can generate different values. This is related to the overall setups of the assays, the antibodies used, the differences in reference materials/methods, and the standardization methodology used. A general reagent issue at customer site most likely can be excluded.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2016-01034 |
| MDR Report Key | 5815040 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-07-22 |
| Date of Report | 2016-07-22 |
| Date of Event | 2016-06-29 |
| Date Mfgr Received | 2016-06-30 |
| Date Added to Maude | 2016-07-22 |
| 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 | 2016-07-22 |
| Model Number | NA |
| Catalog Number | ASKU |
| Lot Number | 189893 |
| ID Number | NA |
| 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 | 2016-07-22 |