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 2018-07-06 for DADE ACTIN FSL ACTIVATED PTT REAGENT 10445713 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[113514824]
Siemens healthcare diagnostics inc. Has investigated the cause of the discordant activated partial thromboplastin time (aptt) patient results generated on the sysmex ca-620 system and determined that the differences observed for the aptt in seconds between the 2 labs can be further explained by a difference in the systems and lot numbers of reagents being used. As stated in the reagent instructions for use, results should be related to the normal range in each laboratory. Reference intervals vary from laboratory to laboratory depending on the population served and the technique, method, equipment and reagent lot used. The aptt results are within the respective normal ranges for each lab. Siemens determined that there is no evidence of a reagent, instrument or software malfunction. The customer service engineer (cse) adjusted the detector well temperature and ran quality control (qc) without issue. The differences observed between the aptt results between the labs is potentially due to the difference in systems and reagent lots used. No further evaluation of this device is required. The systems and reagents are performing according to specifications. Mdr 9610806-2018-00055 was filed for the pt patient results using dade innovin lot 539388.
Patient Sequence No: 1, Text Type: N, H10
[113514825]
Multiple discordant prothrombin time (pt) patient sample results were generated on a sysmex ca-620 system (serial number (b)(4)) and reported to physicians using dade innovin lot 539388 when quality control (qc) for pt was out of range. Some patient samples were run for activated partial thromboplastin time (aptt) using dade actin fsl activated ptt reagent lot 556912. On the following day ((b)(6) 2018), all patient samples were retested at an alternate laboratory on a sysmex cs-2500 system, using dade innovin lot 549704 and dade actin fsl activated ptt reagent lot 556904. No corrected reports were issued to physicians. There are no reports of patient intervention or adverse health consequences due to the differences in aptt results between the two laboratories.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2018-00056 |
| MDR Report Key | 7666615 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-07-06 |
| Date of Report | 2018-07-06 |
| Date of Event | 2018-06-12 |
| Date Mfgr Received | 2018-06-13 |
| Date Added to Maude | 2018-07-06 |
| 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 | 2018-07-06 |
| Catalog Number | 10445713 |
| Lot Number | 556912 |
| Device Expiration Date | 2019-02-14 |
| 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 | 2018-07-06 |