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 2016-06-30 for DADE ACTIN FSL ACTIVATED PTT REAGENT B4219 SMN 10445714 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[48514728]
The cause of the falsely elevated aptt results is unknown. The true recovery of the patient samples is not clear with the information provided. Siemens is unable to rule out improper collection or handling of the samples. Per siemens healthcare support center analysis, the original sample recovery of 62 seconds produced a recovery of 33. 8 seconds when repeat analysis was performed on the same sample after 5 hours. The sample, when aged 5 hours was no longer within acceptable stability for the aptt assay when assessing for unfractionated heparin. Samples collected for coagulation testing for patients on unfractionated heparin therapy must be centrifuged within 1 hour of collection and tested within 4 hours. Delay in centrifugation will lead to platelet neutralization of the heparin in the plasma. If the sample was left in the original tube between the original run and repeat analysis, the platelets may re-suspend in the plasma and also lead to platelet neutralization of the heparin in the plasma. Neutralization of heparin in the plasma would lead to falsely decreased values. The account stated that there may have been a bubble aspirated with the evening sample. The instrument and reagent are performing within specifications per qc results. There were no report of discordant or questionable results on any other patients. No further evaluation of the devices is required.
Patient Sequence No: 1, Text Type: N, H10
[48514729]
A falsely elevated activated ptt (aptt) result was obtained on a patient sample run with the actin fsl reagent on the bcs-xp instrument. The result was reported to the physician. There is no indication if the physician questioned the result or why a repeat test on the same sample was conducted. The sample was repeated 5 hours later and a lower result was obtained which was more consistent with prior results on the same patient. The lower result was regarded as concordant by the laboratory. A corrected report was issued. A subsequent sample was drawn that evening and an elevated result was again obtained. A new sample drawn at noon of that day gave a result in the therapeutic range. The lower result was again regarded as concordant by the laboratory. There is no indication that patient treatment was altered or prescribed on the basis of the initial elevated aptt result. Patient treatment was altered on the basis of the evening elevated aptt result. The heparin dosage was reduced. There is no indication of adverse health consequences to the patient on the basis of the falsely elevated aptt result or due to the heparin dosage reduction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2016-00019 |
| MDR Report Key | 5761191 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-06-30 |
| Date of Report | 2016-06-30 |
| Date of Event | 2016-06-01 |
| Date Mfgr Received | 2016-06-01 |
| Device Manufacturer Date | 2014-08-26 |
| Date Added to Maude | 2016-06-30 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JAMES MORGERA |
| Manufacturer Street | GLASGOW BUSINESS COMMUNITY PO BOX 6101 |
| Manufacturer City | NEWARK DE 197146101 |
| Manufacturer Country | US |
| Manufacturer Postal | 197146101 |
| Manufacturer Phone | 3026318356 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| Manufacturer Street | 76 EMIL VON BEHRING STRASSE |
| Manufacturer City | MARBURG, 35041 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 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 | 2016-06-30 |
| Catalog Number | B4219 SMN 10445714 |
| Lot Number | 547432 |
| Device Expiration Date | 2016-08-03 |
| Operator | MEDICAL TECHNOLOGIST |
| 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 | 76 EMIL VON BEHRING STRASSE MARBURG, 35041 GM 35041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-06-30 |