MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2018-01-10 for DADE ACTIN FS ACTIVATED PTT REAGENT 10284498 (SEE SECTION H10) manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[96946623]
A siemens healthcare diagnostics (siemens) field service engineer (fse) was dispatched to the customer's site to determine the cause of the discordant, falsely elevated activated partial thromboplastin time (aptt) result on the sysmex cs-5100 system. The fse performed an adjustment check on the system and replaced sample probe a and sample probe b. Based on the sysmex cs-5100 system's instructions for use (ifu), error "1000. 1000. 0000 hemolyzed sample" was triggered because the sample was suspected of hemolysis and error "1000. 3000. 0000 lipemic sample" was triggered because the sample was turbid due to lipemia. The operator should "check the reaction curve and follow judgment criteria for the institution". Siemens is investigating the cause of the event. The (b)(4) compliant dade actin fs activated ptt reagent with catalog number 10284498 described, is not marketed in the united states (us) and the pma/510(k) number, is for the us specific dade actin fs activated ptt reagents. The dade actin fs activated ptt reagent lots marketed in the us have catalog numbers 10445712 and 10445710. Mdr 9610806-2018-00008 was filed for the same event.
Patient Sequence No: 1, Text Type: N, H10
[96946624]
A flagged, discordant, falsely elevated, activated partial thromboplastin time (aptt) result was obtained on a patient sample on the sysmex cs-5100 system. The initial discordant result was reported to the physician(s), who did not question the result. The same sample was rerun on the same system, resulting lower. A corrected report was provided to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated aptt result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2018-00007 |
| MDR Report Key | 7180999 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-01-10 |
| Date of Report | 2018-02-02 |
| Date of Event | 2017-12-12 |
| Date Mfgr Received | 2018-01-10 |
| 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 FS ACTIVATED PTT REAGENT |
| Generic Name | DADE ACTIN FS ACTIVATED PTT REAGENT |
| Product Code | GGW |
| Date Received | 2018-01-10 |
| Model Number | DADE ACTIN FS ACTIVATED PTT REAGENT |
| Catalog Number | 10284498 (SEE SECTION H10) |
| Lot Number | 538524 |
| Device Expiration Date | 2019-01-30 |
| 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 |