MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-10-05 for DADE ACTIN FSL ACTIVATED PTT REAGENT 10445713 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[89485948]
A siemens healthcare diagnostics inc. (siemens) technical solutions center (tsc) specialist directed the customer to run a precision test to determine the cause of the potentially discordant activated partial thromboplastin time (aptt) results on the sysmex ca-620 system and the customer did not follow the recommended instructions. The tsc specialist advised the customer to not report patient results until the issue is resolved. The customer indicated the issue is resolved and they refused service. The customer indicated that they stopped experiencing issues once they started using conical cups on internal quality controls. The cause of the potentially discordant aptt results is unknown. The system is performing according to specifications. No further evaluation of this system is required. Mdr 9610806-2017-00107 and mdr 9610806-2017-00108 were filed for the same event.
Patient Sequence No: 1, Text Type: N, H10
[89485949]
A potentially discordant activated partial thromboplastin time (aptt) result was obtained on a patient sample on the sysmex ca-620 system. This result was not reported to the physician. The same patient sample was rerun on the same system, resulting lower. The repeated result was not reported to the physician and the correct result for this patient is unknown. Prior to running the patient sample, the customer experienced issues with the internal quality controls. The customer indicated that internal quality controls recovered within range once she ran internal quality controls in a conical cup, as oppose to running them in sample tubes. The customer indicated that she ran the patient samples after the internal quality control recovered within expected ranges. There are no known reports of patient intervention or adverse health consequences due to the potentially discordant aptt results obtained on this patient sample.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2017-00109 |
| MDR Report Key | 6916861 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-10-05 |
| Date of Report | 2017-10-05 |
| Date of Event | 2017-09-09 |
| Date Mfgr Received | 2017-09-09 |
| Date Added to Maude | 2017-10-05 |
| 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 FSL ACTIVATED PTT REAGENT |
| Generic Name | DADE ACTIN FSL ACTIVATED PTT REAGENT |
| Product Code | GGW |
| Date Received | 2017-10-05 |
| Model Number | DADE ACTIN FSL ACTIVATED PTT REAGENT |
| Catalog Number | 10445713 |
| Lot Number | 547496A |
| Device Expiration Date | 2018-08-10 |
| 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 | 2017-10-05 |