MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,foreign,health profe report with the FDA on 2015-08-04 for TESTOSTERONE II 05200067190 manufactured by Roche Diagnostics.
[6640364]
The customer complained of erroneous results for 1 patient sample tested for testosterone (testosterone ii). The date of event was not provided. It is not known if erroneous results were reported outside of the laboratory. This information has been requested. This medwatch will cover reagent lot 178782. Refer to medwatch with patient identifier (b)(6) for information on reagent lot 183512. The initial 2 testosterone ii result was 1500 ng/dl with data flags which was repeated and confirmed. The sample was repeated by performing a manual 1:10 dilution and the result was 445 ng/dl. These 3 results were obtained with reagent lot 178782. The sample was repeated again by this same method and the result was 588 ng/dl with reagent lot 183512. The customer then performed a serial dilution with the sample and the following results were obtained: * 1:2 dilution result was 1667 ng/dl * 1:4 dilution result was 1218 ng/dl * 1:8 dilution result was 749. 2 ng/dl * 1:16 dilution result was 446. 7 ng/dl * 1:32 dilution result of 80 ng/dl (this result was 2. 50 ng/dl with a data flag prior to multiplying by the dilution factor. ) it is not known which reagent lot the serial dilution was performed with. This information has been requested. The sample was also sent to mass spectrophotometry and the result was 540 ng/dl. The customer believes this is the correct result. It is not known if the patient was adversely affected. This information was requested. The modular e module serial number was (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[14233230]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[22726589]
Date of event was clarified to be (b)(6) 2015. Clarification was received that erroneous results were not reported outside of the laboratory. Clarification was received that the serial dilutions were performed with reagent lot 178782. Clarification was received that the patient was not adversely affected.
Patient Sequence No: 1, Text Type: N, H10
[27150800]
One sample was submitted for investigation and measured with reagent lot 178782. Undiluted tests were run and manually diluted tests were run. The customer's linearity results when performing dilution could be reproduced.
Patient Sequence No: 1, Text Type: N, H10
[29874604]
During further investigation of the sample, measurements performed by liquid chromatography - mass spectrometry confirm that the testosterone ii value of the undiluted patient sample is high (> 150 ng/dl). Further investigation of the data provided by the customer indicates an interference in the patient sample. The interference may be caused by extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium. This is addressed in product labeling.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-03919 |
| MDR Report Key | 4963125 |
| Report Source | 01,05,06,FOREIGN,HEALTH PROFE |
| Date Received | 2015-08-04 |
| Date of Report | 2015-10-29 |
| Date of Event | 2015-07-07 |
| Date Mfgr Received | 2015-07-07 |
| Date Added to Maude | 2015-08-04 |
| 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 II |
| Generic Name | RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE |
| Product Code | CDZ |
| Date Received | 2015-08-04 |
| Model Number | NA |
| Catalog Number | 05200067190 |
| Lot Number | 178782 |
| 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 | 2015-08-04 |