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 2018-02-01 for DADE ACTIN FSL ACTIVATED PTT REAGENT 10445714 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[98983341]
Siemens healthcare diagnostics inc. Evaluated the instrument and information to determine the cause of the discordant high activated partial thromboplastin time (aptt) patient result on the sysmex ca-1500 analyzer. The siemens service engineer checked all alignments for the sample and reagent probe, then checked the mixing of the mixer motor. An adjustment was made to the sample probe. The sample and reagent tubing were checked for leaks with no issues found. No product non-conformance nor system issue could be identified that may have contributed to the discordant high aptt patient result. A potential cause of the event may be related to sample handling or the nature of the sample. The cause of the discordant high aptt patient result generated on the sysmex ca-1500 analyzer is unknown. The instrument and reagent are performing according to specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
[98983342]
A discordant high activated partial thromboplastin time (aptt) patient result of 127. 4 seconds was generated on the sysmex ca-1500 analyzer using dade actin fsl activated ptt reagent lot 547488. This result was reported to the physician who did not question the result. The same patient sample was tested again on the same system (using same reagent lot 547488) and an aptt result of 56. 5 seconds was generated. This result was not reported to the physician. The same patient sample was tested on the same system, but a different dade actin fsl activated ptt reagent lot was used and aptt results of 53. 2 seconds and 53. 3 seconds were generated. These results were not reported to the physician. The patient was redrawn and a new sample was tested on the same system using ptt reagent lot 547488. An aptt result of 55. 9 seconds was generated. This result was reported to the physician. All quality control (qc) was in range before testing. There are no reports of patient intervention or adverse health consequences due to the discordant high, aptt patient result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2018-00019 |
| MDR Report Key | 7233785 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-02-01 |
| Date of Report | 2018-02-01 |
| Date of Event | 2018-01-11 |
| Date Mfgr Received | 2018-01-11 |
| Device Manufacturer Date | 2016-04-20 |
| Date Added to Maude | 2018-02-01 |
| 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 | LORIANN RUSSO |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242287 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| Manufacturer Street | EMIL VON BEHRING STRASSE 76 |
| 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 | 2018-02-01 |
| Catalog Number | 10445714 |
| Lot Number | 547488 |
| Device Expiration Date | 2018-03-30 |
| 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, 35041 GM 35041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-01 |