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 2017-04-26 for ELECSYS TESTOSTERONE II ASSAY 05200067160 manufactured by Roche Diagnostics.
[73805403]
(b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[73805404]
The customer received a complaint from a clinician about a questionable high elecsys testosterone ii assay result for one patient. The type of roche analyzer used by the customer was not provided. Serial numbers (b)(4) were provided. Clarification was requested but was not provided. The initial result was >52. 0 nmol/l. When the clinician sent a different sample from the patient to a commercial laboratory using a siemens analyzer, the result for testosterone was normal. No specific data was provided. There was no allegation of an adverse event. Analyzer performance testing was done.
Patient Sequence No: 1, Text Type: D, B5
[74512994]
Clarification was received that the analyzer involved was cobas 8000 e 602 module serial number was (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[76179183]
A specific root cause could not be identified. Additional information for further investigation was requested but was not provided. Possible causes for the difference in the results include a possible sample mix up or contamination. The calibration and qc data provided showed no issues and verified the reagent performance was okay.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-00890 |
| MDR Report Key | 6521750 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-04-26 |
| Date of Report | 2017-05-02 |
| Date of Event | 2017-03-21 |
| Date Mfgr Received | 2017-04-06 |
| Date Added to Maude | 2017-04-26 |
| 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 | ELECSYS TESTOSTERONE II ASSAY |
| Generic Name | RADIOIMMUNOASSAY, TESTOSTERONE |
| Product Code | CDZ |
| Date Received | 2017-04-26 |
| Model Number | NA |
| Catalog Number | 05200067160 |
| Lot Number | 19105300 |
| 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 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-26 |