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 2018-01-10 for DADE ACTIN FSL ACTIVATED PTT REAGENT 10445714 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[97737956]
The operator indicated that the cause of the event was potentially due to improper mixing of sample tubes. The operator discussed proper specimen handling and mixing with the other technicians in the lab and the operator indicated that they have not experienced any other issues. The operator also ran a precision test on the sysmex ca-1500 system and the precision test recovered within specifications. On 19- sep-2017, siemens healthcare diagnostics (siemens) performed preventative maintenance (pm) on the affected system. A siemens headquarters support center (hsc) specialist further analyzed the event to determine the cause of the discordant, falsely elevated activated partial thromboplastin time (aptt) results on the sysmex ca-1500 system. The hsc specialist determined that quality controls (qcs) were within expected ranges prior to and after running the patient samples. Since the precision data recovered within specifications, there is no indication of a system issue. The hsc specialist determined that variability in aptt results was only observed for samples that were elevated, above the therapeutic range, for monitoring of unfractionated (uf) heparin therapy. Since all results obtained on the affected sample were highly elevated, a change in interpretation of results is not expected. Due to the fact that the repeat result was consistent after re-centrifugation, the discordant result was potentially not due to a pre-analytical sample handling issue. Elevated aptt results of >90 seconds are associated with patients on uf heparin therapy. Proper monitoring of this therapy requires that the sample is collected at the correct time, upon uf heparin therapy administration, to reflect the patient's coagulation status. Samples containing uf heparin should be run within 2 hours of collection and failure to run the patient sample within 2 hours, may lead to neutralization of uf heparin. If the sample was reanalyzed 2 hours after collection, this potentially resulted in the lower aptt recovery. The cause of the event is unknown. The system and reagent are performing according to specifications. No further evaluation of this reagent or system is required.
Patient Sequence No: 1, Text Type: N, H10
[97737957]
Discordant, falsely elevated activated partial thromboplastin time (aptt) results were obtained on a patient sample on the sysmex ca-1500 system. These results were not provided to the physician(s). The same sample was respun and rerun on the same system, resulting lower. This result was reported to the physician(s), who did not question the result. On the following morning, the patient's blood was redrawn and tested for aptt and an aptt result of >139 seconds was obtained on the sample. The sample tube was checked for clots, respun and rerun on the same system. The same aptt result of >139 seconds was obtained on the sample. This result was reported to the physician, who questioned the result. The operator indicated that the result of > 139 seconds was not discordant for this patient. There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated aptt results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2018-00010 |
| MDR Report Key | 7180990 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-01-10 |
| Date of Report | 2018-02-06 |
| Date of Event | 2017-12-14 |
| Date Mfgr Received | 2018-01-11 |
| Date Added to Maude | 2018-01-10 |
| 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 | 2018-01-10 |
| Model Number | DADE ACTIN FSL ACTIVATED PTT REAGENT |
| Catalog Number | 10445714 |
| Lot Number | 556907 |
| Device Expiration Date | 2018-12-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2018-01-10 |