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 2018-11-02 for DADE ACTIN FSL ACTIVATED PTT REAGENT 10445714 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[125915876]
The customer contacted a siemens customer care center (ccc) and reported that quality control (qcs) recovered out of range(s) for d-dimer and activated partial thromboplastin time (aptt) on the sysmex cs-2500 system. While no patient samples were run for d-dimer when qcs recovered out of ranges, discordant, falsely elevated aptt results were obtained on patient samples. There were no reports of system errors generated when the discordant aptt results were obtained. A siemens customer service engineer (cse) was dispatched to the customer's site. The cse reported that the issue was resolved before he arrived and when the cse ran qcs, the qcs recovered within acceptable ranges for d-dimer and aptt. The cse inspected the mechanical positions on the system and determined that adjustments were not required. Then, the cse observed an error in system's error log ("error in hydraulic line for rinse cup ejection in sample probe") and determined that the sample cup rinse was not being drained fast enough, causing an overflow; the cse bleached valve 2 and the rinse drain operated acceptably. The cse reported that qcs were within acceptable ranges prior to and after the cse bleached valve 2. Siemens further investigated the issue and determined that the sample cup rinse overflow may have contributed to the discordant, falsely elevated aptt results. Siemens reached out to the customer with questions regarding the affected patient samples and impacted reagent lots, and how the issue was resolved prior to the cse's visit; however, the customer has not responded thus far. The lot number and unique identifier number (udi) for the dade actin fsl activated ptt reagent were not available at the time of filing this mdr. The reagent is performing according to specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
[125915877]
Discordant, falsely elevated activated partial thromboplastin time (aptt) results were intermittently obtained on patient samples on a sysmex cs-2500 system, using the dade actin fsl activated ptt reagent, on (b)(6) 2018. The discordant results were reported to the physician(s). When the samples were repeated on an alternate sysmex ca-1500 system, lower results were obtained on the samples. The repeat results were reported, as the correct results, to the physician(s). The customer reported that they transferred all patient samples to the sysmex ca-1500 system for testing. There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated aptt results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2018-00113 |
| MDR Report Key | 8032166 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-11-02 |
| Date of Report | 2018-11-02 |
| Date of Event | 2018-10-08 |
| Date Mfgr Received | 2018-10-09 |
| Date Added to Maude | 2018-11-02 |
| 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 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 FSL ACTIVATED PTT REAGENT |
| Generic Name | DADE ACTIN FSL ACTIVATED PTT REAGENT |
| Product Code | GGW |
| Date Received | 2018-11-02 |
| Model Number | DADE ACTIN FSL ACTIVATED PTT REAGENT |
| Catalog Number | 10445714 |
| 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- STR. 76 MARBURG, D-35041 GM D-35041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-02 |