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 2017-04-25 for DADE ACTIN FSL ACTIVATED PTT REAGENT 10445714 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[73620168]
A siemens healthcare diagnostics inc. (siemens) field service engineer (fse) was dispatched to the customer site to determine the cause of the discordant low activated partial thromboplastin time (aptt) results on the sysmex cs-5100 system and found no issues. The customer checked the aptt results and their reaction curves for 300 patient samples that were ran prior to and after this incident and did not find any discordant results. The internal controls were within the expected ranges. Siemens investigation determined that the reagents had expired 6 days prior to the incident. The cause of the event is user error. The device is performing according to specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
[73620169]
A discordant, falsely low activated partial thromboplastin time (aptt) result was obtained on a sysmex cs-5100 system. The initial run was flagged by the instrument with an early reaction error- slow reaction without an aptt result. The sample was automatically rerun with a longer measurement time and received the same flag without an aptt result. The customer ultra-centrifuged the sample, reran it and received two results (30. 5 seconds and 36. 4 seconds) with no error flags. The result was automatically sent out to the hospital ward since the cs-5100 system did not flag the results. The customer noticed a difference in patient sample results and noticed that the reaction curve was incorrect. The operator immediately recalled the result based on the erroneous reaction curve. The patient's blood was re-drawn and run on a different sysmex cs-5100 system. The operator manually assessed the coagulation curve for the repeated result and obtained an accurate reaction curve. The repeated aptt result (98 seconds) was 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 | 9610806-2017-00053 |
| MDR Report Key | 6519057 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-04-25 |
| Date of Report | 2017-04-25 |
| Date of Event | 2017-03-07 |
| Date Mfgr Received | 2017-03-31 |
| Date Added to Maude | 2017-04-25 |
| 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 | ELIZABETH BERNASCONI |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9146216083 |
| 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 FSL ACTIVATED PTT REAGENT |
| Generic Name | DADE ACTIN FSL ACTIVATED PTT REAGENT |
| Product Code | GGW |
| Date Received | 2017-04-25 |
| Model Number | DADE ACTIN FSL ACTIVATED PTT REAGENT |
| Catalog Number | 10445714 |
| Lot Number | 547461A |
| Device Expiration Date | 2017-03-02 |
| 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 | 2017-04-25 |