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 2015-01-07 for ELECSYS TESTOSTERONE II IMMUNOASSAY 05200067190 manufactured by Roche Diagnostics.
[5121066]
The customer reported that they received an erroneous testosterone result for one patient sample. It was asked, but it is not known when the date of the event occurred. It was also asked, but not known what instrument model and serial number was used to initially run the sample. The sample was initially tested on an elecsys instrument and resulted as 156. 1 ng/dl. The initial result was sent to another hospital with a comment of "wrong method". The same sample was repeated the next day using lc-ms methodology and resulted as 5. 2 ng/dl. It was asked, but it is not known if the patient was adversely affected. No adverse events were alleged.
Patient Sequence No: 1, Text Type: D, B5
[12730991]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[12782731]
A new sample was collected from the patient and tested using both the elecsys testosterone method and lc/ms. This time, the measurements for lc/ms and the elecsys were in the same range and the results confirmed the initial results on the elecsys analyzer. No specific results were provided. From this information, it appears the discrepancy in the initial sample measurements were likely due to pre-analytic sample handling of the tube used for lc/ms testing. The customer has concluded the initial testosterone results on the elecsys system were correct and the results from the initial lc/ms measurements were false. A general reagent issue was not found to be present.
Patient Sequence No: 1, Text Type: N, H10
[12822583]
The sample was initially tested on an e602 analyzer. A specific root cause could not be determined. Additional information required for investigation was requested, but not provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-00096 |
| MDR Report Key | 4393673 |
| Report Source | 01,05,06 |
| Date Received | 2015-01-07 |
| Date of Report | 2015-01-27 |
| Date of Event | 2014-12-15 |
| Date Mfgr Received | 2014-12-15 |
| Date Added to Maude | 2015-01-07 |
| 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 | ELECSYS TESTOSTERONE II IMMUNOASSAY |
| Generic Name | RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE |
| Product Code | CDZ |
| Date Received | 2015-01-07 |
| Model Number | NA |
| Catalog Number | 05200067190 |
| Lot Number | ASKU |
| 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 | 2015-01-07 |