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.
[83686048]
Siemens healthcare diagnostics inc. (siemens) analyzed sysmex cs-5100 system backup files provided by the customer. Siemens did not identify any systemic issues on the sysmex cs-5100 system. The system produced non-numerical aptt results, which signify that "analysis result could not be obtained due to errors and other problems". Based on the sysmex cs-5100 system operator's guide, the results were flagged because "an abnormal reaction was detected at the initial stage of the aptt coagulation reaction" and "the coagulation reaction was not detectable, due to low fibrinogen concentration, an anticoagulant sample or a reagent problem. The operator should "check the coagulation curve and follow the judgment criteria for your institution. Alternatively, check the volumes of sample and reagent, then repeat the test. " the operator incorrectly reported the time (in seconds) that corresponded to 50% of the coagulation curve to the physician. The cause of the event is due to user error. The instrument and reagents are performing according to specifications. No further evaluation of this device is required. Mdr 9610806-2017-00083, mdr 9610806-2017-00085, mdr 9610806-2017-00086, and mdr 9610806-2017-00087 were filed for the same event.
Patient Sequence No: 1, Text Type: N, H10
[83686049]
Non-numerical flagged activated partial thromboplastin time (aptt) results were obtained on two patient samples on the sysmex cs-5100 system. The customer incorrectly reported the time (in seconds) that corresponded to 50% of the coagulation curve for one sample to the physician. The patient blood was redrawn twice and run on the same system, resulting in two aptt results. A discordant, falsely low aptt result and a correct aptt result were reported to the physician. The physician misinterpreted the system's early reaction error as short coagulation time. The patient blood was redrawn again on the next day and run on the same system. An aptt result without flag(s) was obtained and provided to the physician. There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low aptt results reported to the physician.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2017-00084 |
| MDR Report Key | 6789733 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-08-11 |
| Date of Report | 2017-08-11 |
| Date of Event | 2017-07-13 |
| 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 |