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 2017-11-29 for DADE ACTIN FSL ACTIVATED PTT REAGENT 10445713 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[94200158]
A siemens healthcare diagnostics inc. (siemens) customer service engineer (cse) was dispatched to the customer site to determine the cause of the discordant, falsely elevated activated partial thromboplastin time (aptt) result on the sysmex ca-560 system. The cse checked the temperature, alignments, syringe, probe, and mixing on the system and found no issues. The cse ran a prothrombin time (pt) precision test and an aptt precision test using primary tubes and ran quality controls (qcs) on the system. The precision tests and qcs recovered within expected ranges. The cse also calibrated the detectors and performed a bleach drain on the system. The customer indicated that there were no hardware errors on the error list on the affected system and that all qcs recovered within range since the event. A siemens technical support specialist (tst) discussed proper mixing of sample tubes with the customer. The customer indicated that, at their site, only phlebotomists draw patients' blood and they are taught to invert the tube 5-10 times after drawing the patient sample. A sample handling or collection issue may have contributed to the discordant aptt result on the patient sample. Improper mixing post blood draw may have caused poor anticoagulation or anticoagulant to be in the upper portion of the plasma sample, potentially causing the discordant prolonged clot time. When the plasma was transferred to the sample cup, this induced additional mixing, potentially leading to a lower result. The cause of the discordant, falsely elevated aptt result is unknown. The system and reagent are performing according to specifications. No further evaluation of this system or reagent is required. Mdr 9610806-2017-00137 was filed for the same event.
Patient Sequence No: 1, Text Type: N, H10
[94200159]
A discordant, falsely elevated activated partial thromboplastin time (aptt) result was obtained on a patient sample tube on the sysmex ca-560 system. This discordant result was reported to the physician, who did not question the result. The same sample was transferred to a sample cup and rerun on the same system, resulting lower. The patient's blood was redrawn and run in a primary tube and in a sample cup on the same system, resulting lower than the initial result. The aptt result obtained on the redrawn sample tube was reported to the physician. 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 | 9610806-2017-00138 |
| MDR Report Key | 7068659 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-11-29 |
| Date of Report | 2017-11-29 |
| Date of Event | 2017-11-02 |
| Date Mfgr Received | 2017-11-02 |
| Date Added to Maude | 2017-11-29 |
| 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 | 2017-11-29 |
| Model Number | DADE ACTIN FSL ACTIVATED PTT REAGENT |
| Catalog Number | 10445713 |
| Lot Number | 547496A |
| Device Expiration Date | 2018-08-10 |
| 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 | 2017-11-29 |