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 2017-08-11 for DADE ACTIN ACTIVATED CEPHALOPLASTIN REAGENT 10445711 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[83685357]
Siemens healthcare diagnostics inc. (siemens) analyzed sysmex cs-5100 system backup files provided by the customer to determine the cause of the discordant, falsely low aptt results on the sysmex cs-5100 system. Siemens did not identify any systemic issues with the sysmex cs-5100 system. The cause of the event is unknown. The instrument and reagents are performing according to specifications. No further evaluation of this device is required. Mdr 9610806-2017-00083, mdr 9610806-2017-00084, mdr 9610806-2017-00085, and mdr 9610806-2017-00087 were filed for the same event.
Patient Sequence No: 1, Text Type: N, H10
[83685358]
Two discordant, falsely low activated partial thromboplastin time (aptt) results were obtained on a patient sample on the sysmex cs-5100 system. One result was obtained by mixing a test in a one-to-one dilution with the patient sample and the other was obtained by adding polybrene. These results were reported to the physician and it is unknown whether the physician questioned these results. On (b)(6) 2017, correct aptt results from other samples of the same patient were reported to the physician. 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 | 9610806-2017-00086 |
| MDR Report Key | 6789762 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-08-11 |
| Date of Report | 2017-08-11 |
| Date of Event | 2017-07-15 |
| Date Mfgr Received | 2017-07-18 |
| Date Added to Maude | 2017-08-11 |
| 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 | 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 ACTIVATED CEPHALOPLASTIN REAGENT |
| Generic Name | DADE ACTIN ACTIVATED CEPHALOPLASTIN REAGENT |
| Product Code | GFO |
| Date Received | 2017-08-11 |
| Model Number | DADE ACTIN ACTIVATED CEPHALOPLASTIN REAGENT |
| Catalog Number | 10445711 |
| Lot Number | 557236A |
| Device Expiration Date | 2018-11-30 |
| 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 | 2017-08-11 |