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 2016-07-26 for TESTOSTERONE G2 05200067190 manufactured by Roche Diagnostics.
[50437025]
This event occurred in (b)(6). The full facility name was provided as (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[50437026]
The customer stated that they received erroneous high results for one patient sample tested for testosterone on an e601 analyzer. An aliquot of the serum tube of the sample initially resulted as 1006 ng/dl. The customer decided to repeat the sample since the initial value was very high for a woman. The primary serum tube was repeated, resulting as 958. 7 ng/dl. To confirm the result and to rule out an issue with fibrin interference, the plasma tube of the sample was tested on (b)(6) 2016, resulting as 493. 0 ng/dl. The 493. 0 ng/dl value was reported outside of the laboratory since it was a smaller value. A roche application specialist repeated the serum sample on (b)(6) 2016 and it resulted as 913. 7 ng/dl. The physician was contacted by the customer and the physician stated that none of the high results, including the 493. 0 ng/dl value, were expected. The customer did not know which value was correct. The patient was not adversely affected. The e601 analyzer serial number was (b)(4). The serum and plasma tubes of the sample were tested to ensure both sample tubes were from the same patient. The urea results for both tubes were found to be the same.
Patient Sequence No: 1, Text Type: D, B5
[55058487]
A specific root cause could not be determined based on the provided information. Additional information required for the investigation was requested, but not provided. The affected samples were also requested for investigation, but could not be provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-01069 |
| MDR Report Key | 5822117 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-07-26 |
| Date of Report | 2016-09-14 |
| Date of Event | 2016-07-11 |
| Date Mfgr Received | 2016-07-12 |
| Date Added to Maude | 2016-07-26 |
| 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 | TESTOSTERONE G2 |
| Generic Name | RADIOIMMUNOASSAY, TESTOSTERONE |
| Product Code | CDZ |
| Date Received | 2016-07-26 |
| Model Number | NA |
| Catalog Number | 05200067190 |
| Lot Number | 137627 |
| 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 | 2016-07-26 |