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 2017-10-13 for DADE ACTIN FS ACTIVATED PTT REAGENT 10284498 (SEE SECTION H10) manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[90310277]
A siemens healthcare diagnostics inc. (siemens) headquarters support center (hsc) specialist analyzed one of the bcs xp system (serial (b)(4)) backup files to determine the cause of the discordant low activated partial thromboplastin time (aptt) results. The hsc specialist determined that the reagent vial used to obtain the aptt results on these patient samples was used for previous patient samples and that there were no issues with internal quality controls and other samples. The hsc specialist determined that the kinetics of the coagulation reactions were unexpected for the aptt assay and determined that the flags were plausible since the kinetics show very high absorbance. The high absorbance confirmed that the affected samples were lipemic. The lipemic samples and other sample specific issues potentially contributed to the unexpected reaction curves and the discordant results. There is no indication of either a systemic or reagent performance issue at the time of the event. The backup files of the bcs xp system (serial (b)(4)) were not available at the time of reporting this incident. The cause of the discordant, falsely low aptt results is unknown. The reagent is performing according to specifications. No further evaluation of the reagent is required. The rilib? K compliant dade actin fs activated ptt reagent with catalog number 10284498 described in model #/lot # is not marketed in the united states (us) and the pma/510(k) number is for the us specific 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
[90310278]
A flagged, discordant, falsely low activated partial thromboplastin time (aptt) result was obtained on a lipemic patient sample on the bcs xp system. The same patient sample was run using the backup assay at 570 nm on the same system, resulting lower. The customer validated the result on the laboratory information system (lis) and released the result to the emergency department of the clinic. The physician questioned the low aptt result. The patient's blood was redrawn and run on an alternate bcs xp system using the backup assay at 570 nm, resulting lower. The redrawn lipemic patient sample was centrifuged and rerun on the alternate bcs xp system using the backup assay at 570 nm, resulting higher than previous results. The customer manually evaluated the coagulation reaction on this kinetic measuring curve and reported the result that they manually obtained to the physician. The reported result matched the patient's expected result range and clinical condition. The original patient sample was centrifuged and rerun on the alternate system- resulting in a flagged, but expected, aptt result. There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low aptt results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2017-00115 |
| MDR Report Key | 6947322 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-10-13 |
| Date of Report | 2017-10-13 |
| Date of Event | 2017-09-20 |
| Date Mfgr Received | 2017-09-20 |
| Date Added to Maude | 2017-10-13 |
| 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 | 2017-10-13 |
| Model Number | DADE ACTIN FS ACTIVATED PTT REAGENT |
| Catalog Number | 10284498 (SEE SECTION H10) |
| Lot Number | 538521 |
| Device Expiration Date | 2018-11-22 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2017-10-13 |