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 2018-05-11 for DADE ACTIN FS ACTIVATED PTT REAGENT 10284498 (SEE SECTION H10) manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[108161305]
The customer contacted siemens customer care center and reported that a discordant, falsely elevated activated partial thromboplastin time (aptt) result was obtained using the dade actin fs activated ptt reagent from lot 538524. The customer reported that they observed flocculation in the reagent vials and that quality controls (qcs) were within expected ranges on the day of the event. The customer provided an affected reagent vial and an unaffected reagent vial for further investigation. Siemens ran a study using internal dade actin fs activated ptt reagent vials from lot 538524 and the reagent vials provided by the customer. Siemens determined that qcs recovered within table of assigned values (tavs) ranges using the customer's vial without flocculation and outside of tavs ranges using the customer's vials with flocculation. Five normal patient samples and fresh frozen plasma were also tested for aptt using these vials; the results obtained using unaffected reagent vial provided by the customer and the internal reagent vials recovered as expected. The results obtained using the affected reagent vial recovered higher than expected. Siemens investigated the log files and determined that the affected reagent vial was changed directly before the discordant result was obtained. The customer reported that they switched to another dade actin fs activated ptt reagent lot 538546. The cause of the event is unknown. No further evaluation of this device is required. The rilib? K compliant dade actin fs activated ptt reagent with catalog number 10284498 described is not marketed in the united states (us) and the pma/510(k) number is for the us specific dade actin fs activated ptt reagents. The dade actin fs activated ptt reagent lots marketed in the us have catalog numbers 10445712 and 10445710.
Patient Sequence No: 1, Text Type: N, H10
[108161306]
A discordant, falsely elevated activated partial thromboplastin time (aptt) result was obtained on a patient sample using the dade actin fs activated ptt reagent from lot 538524 on the sysmex cs-2500 system. The discordant result was reported to the physician(s), who questioned the result. The same sample was rerun twice, using another vial of dade actin fs activated ptt reagent from lot 538524, and expected results were obtained. The result obtained using the alternate reagent vial was reported, as the correct result, to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated aptt result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2018-00047 |
| MDR Report Key | 7508851 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-05-11 |
| Date of Report | 2018-06-08 |
| Date of Event | 2018-04-16 |
| Date Mfgr Received | 2018-05-16 |
| Date Added to Maude | 2018-05-11 |
| 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 | CHRISTINA LAM |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243504 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| Manufacturer Street | EMIL-VON-BEHRING- STR. 76 |
| Manufacturer City | MARBURG, D-35041 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-35041 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DADE ACTIN FS ACTIVATED PTT REAGENT |
| Generic Name | DADE ACTIN FS ACTIVATED PTT REAGENT |
| Product Code | GGW |
| Date Received | 2018-05-11 |
| Model Number | DADE ACTIN FS ACTIVATED PTT REAGENT |
| Catalog Number | 10284498 (SEE SECTION H10) |
| Lot Number | 538524 |
| Device Expiration Date | 2019-01-30 |
| 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 PRODUCTS GMBH |
| Manufacturer Address | EMIL-VON-BEHRING- STR. 76 MARBURG, D-35041 GM D-35041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-11 |