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 2018-10-12 for DADE ACTIN FSL ACTIVATED PTT REAGENT 10445714 manufactured by Siemens Healthcare Diagnostics Product Gmbh.
[125143751]
A customer contacted a siemens customer care center (ccc) and indicated that they obtained discordant activated partial thromboplastin time (aptt) results on a patient sample using the dade actin fsl activated ptt reagent. As per siemens' instructions, the customer performed a precision study using quality controls, resulting acceptably. Siemens investigated the instrument files and observed that the samples were flagged with err 128 (early reaction error) and err 004 (analysis time over). The sysmex ca-1500 system advises customers that an abnormal reaction was detected at the initial stage of the coagulation because of a reagent problem and to check the coagulation curve, increase the maximum detection time and check the status of the sample and reagent for re-analysis when these errors are triggered during sample analysis. Quality controls (qcs) recovered within lab ranges on the day of the event. The customer suspected that the samples were contaminated. Siemens further investigated the event and determined that there were no mechanical or analysis errors, indicating there were no system malfunctions. Siemens concluded that the cause of the discordant, falsely low aptt result was sample specific and was potentially caused by pre-analytical factors. The system and reagent are performing according to specifications. No further evaluation of these devices is required. Mdr 9610806-2018-00104 was filed for the same issue.
Patient Sequence No: 1, Text Type: N, H10
[125143752]
A flagged, elevated activated partial thromboplastin time (aptt) result was obtained on a patient sample using the dade actin fsl activated ptt reagent on a sysmex ca-1500 system. The sample was repeated on an alternate sysmex ca-1500 system using the same reagent lot, resulting in another elevated aptt result. The sample was repeated on the initial system and a discordant, falsely low result was obtained. The sample was repeated twice on the alternate system, resulting in flagged, elevated aptt results. The customer reported the aptt result of >200 seconds, as the correct result, to the physician(s). The patient was redrawn and the new sample was run on one of the systems; a result of >200 seconds was obtained on the re-drawn sample. There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low aptt results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2018-00105 |
| MDR Report Key | 7962392 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-10-12 |
| Date of Report | 2018-10-12 |
| Date of Event | 2018-09-19 |
| Date Mfgr Received | 2018-09-19 |
| Device Manufacturer Date | 2017-10-11 |
| Date Added to Maude | 2018-10-12 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 PRODUCT 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 FSL ACTIVATED PTT REAGENT |
| Generic Name | DADE ACTIN FSL ACTIVATED PTT REAGENT |
| Product Code | GGW |
| Date Received | 2018-10-12 |
| Model Number | DADE ACTIN FSL ACTIVATED PTT REAGENT |
| Catalog Number | 10445714 |
| Lot Number | 556922A |
| Device Expiration Date | 2019-10-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCT GMBH |
| Manufacturer Address | EMIL-VON-BEHRING-STR 76 MARBURG, D-35041 GM D-35041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-12 |