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 2018-04-20 for DADE ACTIN FSL ACTIVATED PTT REAGENT 10445714 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[106251688]
A customer contacted siemens customer care center (ccc) and indicated that they obtained discordant activated partial thromboplastin time (aptt) results on multiple patient samples using the dade actin fsl activated ptt reagent. The customer indicated that there were no errors in the sysmex ca-1500 system's error logs and quality controls (qcs) recovered within lab ranges prior to running the patient samples for aptt and other assays. The customer also reported that qcs were rerun after the affected patient samples were initially run, recovering out of lab ranges. Then, the customer replaced the dade actin fsl activated ptt reagent, dade ca system buffer, calcium chloride, qc, and detergent rinse and ran qcs, which recovered within lab ranges. The customer suspected that contamination or a use error potentially impacted the initial results. A siemens customer service engineer (cse) was dispatched to the customer's site. The cse inspected the instrument and did not detect any malfunction; as per the customer's request, the cse checked the sample and reagent probe systems for micro holes and did not find any. Then, the customer ran qcs, which recovered within lab ranges. Siemens further investigated the event and determined that no mechanical or analysis errors were triggered when the samples were initially run. Siemens concluded that contamination, due to a handling or storage issue, potentially contributed to the discordant, falsely low aptt results. The system and reagent are performing according to specifications. No further evaluation of these devices is required.
Patient Sequence No: 1, Text Type: N, H10
[106251689]
Discordant, falsely low activated partial thromboplastin time (aptt) results were obtained on multiple patient samples using the dade actin fsl activated ptt reagent on the sysmex ca-1500 system. The initial results were reported to the physician(s). The same samples were rerun using fresh reagents, from the same lot, resulting higher. The repeat results were reported, as the correct results, to the physician(s) for twelve patients; the customer indicated that the remaining patients did not require corrected reports. It is unknown whether the patients were on anticoagulation or heparin therapy. 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 | 9610806-2018-00043 |
| MDR Report Key | 7446151 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-04-20 |
| Date of Report | 2018-04-20 |
| Date of Event | 2018-02-08 |
| Date Mfgr Received | 2018-03-28 |
| Date Added to Maude | 2018-04-20 |
| 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 FSL ACTIVATED PTT REAGENT |
| Generic Name | DADE ACTIN FSL ACTIVATED PTT REAGENT |
| Product Code | GGW |
| Date Received | 2018-04-20 |
| Model Number | DADE ACTIN FSL ACTIVATED PTT REAGENT |
| Catalog Number | 10445714 |
| Lot Number | 547492 |
| Device Expiration Date | 2018-04-05 |
| 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 | 2018-04-20 |