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 2016-04-11 for TESTOSTERONE G2 05200067190 manufactured by Roche Diagnostics.
[42383667]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[42383668]
The customer complained of erroneous results for two patients tested for testosterone ii from cobas e601 with the serial number (b)(4). The first patient's o was tested on (b)(6) 2016. The original result was 1158 ng/dl on the cobas e601 module (serial number (b)(4)). The sample was sent to a second laboratory and tested by clia. The result was 660 ng/dl. The second patient was male and (b)(46 years old. He was tested on (b)(6) 2016. The testosterone result was 1265 ng/dl and the sample was sent to a second laboratory. That result by clia was 539 ng/dl. The erroneous results were reported outside of the laboratory. There was no adverse event. The patient samples were requested for investigation.
Patient Sequence No: 1, Text Type: D, B5
[45232104]
The volume of the samples returned for investigation was insufficient and could not be investigated. The calibration and qc data provided for investigation were within specifications. Performance testing of the analyzer indicated the instrument was performing to specifications. A specific root cause for the event could not be determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-00423 |
| MDR Report Key | 5567195 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-04-11 |
| Date of Report | 2016-05-16 |
| Date of Event | 2016-03-18 |
| Date Mfgr Received | 2016-03-24 |
| Date Added to Maude | 2016-04-11 |
| 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 | TESTOSTERONE G2 |
| Generic Name | RADIOIMMUNOASSAY, TESTOSTERONE |
| Product Code | CDZ |
| Date Received | 2016-04-11 |
| Model Number | NA |
| Catalog Number | 05200067190 |
| Lot Number | 187861 |
| 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 | 2016-04-11 |