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 2017-02-16 for DADE ACTIN FSL B4219-2 SMN 10445714 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[67544448]
The cause of the discordant elevated aptt result is unknown. The customer stated that quality control was within laboratory ranges and there have been no issues with other patient samples. After the 180. 7 seconds result was reported, the account stated that they notified the nurse that they were unable to report further aptt results on this patient due to interfering substances in the sample as they are not sure which result is correct. The siemens headquarters support center (hsc) representative evaluated the information provided. The discordant elevated result of 2:54 am (b)(6) 2017 of 180. 7 raw seconds is a prolonged value and is consistent with ufh therapy. The patient sample was noted as slightly lipemic. Aptt testing was requested to monitor the patient for unfractionated heparin (ufh) therapy. The bcs xp system performed as expected, sample result flags were appropriately generated. The laboratory followed manufacturer's guidelines as well as good laboratory practice and all reported values on the patient were appropriate. The laboratory proactively informed the physician of the challenge with obtaining consistent aptt results on this patient due to a potential interfering substance. The physician elected to use an alternate anticoagulant, argatroban. Aptt testing since this time has been consistent and reportable. There is no report of harm to the patient. This is an isolated incident and there is no evidence of a systemic product non-conformance. The device is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[67544449]
A discordant elevated activated partial thromboplastin time (aptt) result was obtained on a patient sample run with the actin fsl reagent on the bcs-xp analyzer. The elevated result was reported to the physician. The patient anticoagulant treatment was altered on the basis of the discordant elevated aptt result. The patient was taken off heparin treatment and switched to the anticoagulant argatroban. There is no indication of adverse health consequences to the patient on the basis of the discordant elevated aptt result or the change in anticoagulant treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2017-00023 |
| MDR Report Key | 6335159 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-02-16 |
| Date of Report | 2017-02-16 |
| Date of Event | 2017-01-17 |
| Date Mfgr Received | 2017-01-17 |
| Device Manufacturer Date | 2016-01-20 |
| Date Added to Maude | 2017-02-16 |
| 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 | JAMES MORGERA |
| Manufacturer Street | GLASGOW BUSINESS COMMUNITY 500 GBC DRIVE 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 | EMIL VON BEHRING STRASSE 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 |
| Generic Name | DADE ACTIN FSL ACTIVATED PTT REAGENT |
| Product Code | GGW |
| Date Received | 2017-02-16 |
| Catalog Number | B4219-2 SMN 10445714 |
| Lot Number | 547475 |
| Device Expiration Date | 2018-01-03 |
| 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 STRASSE 76 MARBURG, D-35041 GM D-35041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-16 |