MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-02-01 for COAT-A-COUNT FREE TESTOSTERONE TKTF manufactured by Siemens Healthcare Diagnostics.
[3282536]
Discordant, falsely low free testosterone results were obtained on patient samples on an ria instrument using coat-a-count free testosterone lots 1458, 1462, and 1463. It is unknown if the discordant results were reported to the physician(s). The samples were rerun at a reference laboratory, and higher results were obtained. There are no reports of patient intervention or adverse health consequences due to the falsely low free testosterone results.
Patient Sequence No: 1, Text Type: D, B5
[10493011]
The cause of the discordant, falsely low free testosterone results is unknown. Siemens is investigating this issue.
Patient Sequence No: 1, Text Type: N, H10
[26368649]
The initial mdr 2432235-2013-00046 was filed on february 1, 2013. The first follow-up mdr 2432235-2013-00046_s1 was filed on august 9, 2013. Correction (8/13/13): the mdrs for this event were incorrectly filed with the registration number (b)(4). The correct registration number for ria free testosterone kits is (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[26368657]
The initial mdr 2432235-2013-00046 was filed on february 1, 2013. Additional information (7/17/13): siemens technical operations confirmed that internal testing of ria free testosterone kit lots 1458, 1462, and 1463 had been performed and all three kits were released within the manufacturer specifications. Siemens global product support has not received complaints from any other customers about ria free testosterone kit lots 1458, 1462, and 1463. Additional information (8/9/13): during follow-up with the customer, the customer stated that the physician(s) who had questioned the low results have not had any more questions or concerns about results obtained.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2013-00046 |
| MDR Report Key | 2939976 |
| Report Source | 05,06 |
| Date Received | 2013-02-01 |
| Date of Report | 2013-01-04 |
| Date of Event | 2012-01-14 |
| Date Mfgr Received | 2013-08-13 |
| Date Added to Maude | 2013-04-18 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | CASSANDRA KOCSIS |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242687 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Street | 5736 WEST 96TH STREET |
| Manufacturer City | LOS ANGELES CA 90045 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 90045 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COAT-A-COUNT FREE TESTOSTERONE |
| Generic Name | COAT-A-COUNT FREE TESTOSTERONE |
| Product Code | GKL |
| Date Received | 2013-02-01 |
| Model Number | COAT-A-COUNT FREE TESTOSTERONE |
| Catalog Number | TKTF |
| Lot Number | 1458; 1462; 1463 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Address | 5736 WEST 96TH STREET LOS ANGELES CA 90045 US 90045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-02-01 |