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 2016-01-08 for ELECSYS TESTOSTERONE II IMMUNOASSAY manufactured by Roche Diagnostics.
[35494536]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[35494537]
The customer reported that the values obtained with a roche instrument for one sample tested for the following tests did not fit the clinical picture of the patient: testosterone (testo), dehydroepiandrosterone sulfate (dhea-s), antibodies to tsh receptor (anti-tshr), free triiodothyronine (ft3), free thyroxine (ft4), and thyrotropin (tsh). Testo, dhea-s, anti-tshr, ft3, and ft4 values were said to be very high. The tsh value was said to be normal. The sample was tested for anti-tpo and anti-thyroglobulin using the liaison testing method and the results for these tests were positive. The sample was also tested for androstanediol glucuronide and androstenedione using a ria testing method and results from these tests were normal. The results obtained with the roche methods and other methods were said to not fit with each other. All results were sent to the physician. The customer also mentioned that another sample was collected from the patient in the same year and tested for the same tests using the roche method at a different laboratory and these results were similar to the sample in question. No specific result values were provided for any of the questioned samples. This medwatch will cover testo. Refer to the medwatches with patient identifier (b)(6) for information related to ft3, patient identifier (b)(6) for information related to ft4, patient identifier (b)(6) for information related to tsh, patient identifier (b)(6) for information related to dhea-s, and patient identifier (b)(6) for information related to anti-tshr. The patient was not adversely affected. The analyzer model and serial number used for testing was asked for, but not provided.
Patient Sequence No: 1, Text Type: D, B5
[36617588]
The customer has provided the patient data. Including relevant test data. Data was provided for samples from the same patient tested on (b)(6) 2013, (b)(6) 2015, and for the complained sample tested on (b)(6) 2015. In the attachment, the ft3 test is referred to as "t3 libre", ft4 is referred to as "t4 libre", anti-tshr is referred to as "anti-thyroglobuline", testo is referred to as "testosterone totale", and dhea-s is referred to as "dhea sulfate".
Patient Sequence No: 1, Text Type: N, H10
[38788281]
The customer provided data for a new sample that was tested from the patient on 01/28/2016. The sample was said to have similar values to previous samples. (b)(4). In the attachment, the ft3 test is referred to as "t3 libre", ft4 is referred to as "t4 libre", anti-tshr is referred to as "anti-thyroglobuline", testo is referred to as "testosterone totale", and dhea-s is referred to as "dhea sulfate". The patient was not suffering from a known renal insufficiency, a known liver insufficiency, or a known malignant disease. The patient was not pregnant. (b)(4)
Patient Sequence No: 1, Text Type: N, H10
[40658161]
A sample from the patient was provided for investigation. Investigation of the sample determined that it contains an interfering factor to streptavidin. This interfering factor caused the result difference seen with the testosterone assay. This limitation is covered in product labeling.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-00019 |
| MDR Report Key | 5355219 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-01-08 |
| Date of Report | 2016-03-17 |
| Date of Event | 2015-12-17 |
| Date Mfgr Received | 2015-12-21 |
| Date Added to Maude | 2016-01-08 |
| 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 IMMUNOASSAY |
| Generic Name | RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE |
| Product Code | CDZ |
| Date Received | 2016-01-08 |
| Model Number | NA |
| Catalog Number | ASKU |
| 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 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-01-08 |