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 2017-10-24 for DADE ACTIN FSL ACTIVATED PTT REAGENT 10445714 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[90861872]
A siemens healthcare diagnostics inc. (siemens) headquarters support center (hsc) specialist reviewed the data printouts and internal quality controls to determine the cause of flagged, non-numerical results on the sysmex cs-2500 system and the sysmex cs-5100 system. The hsc specialist determined that the internal quality controls recovered within range on both systems and the issue is isolated to two samples from the affected patient. The hsc specialist determined that the customer followed siemens's procedure and good laboratory practices when evaluating the abnormal and flagged results. The results obtained using sample (b)(6) were not reportable and the customer did not report these results. The customer appropriately requested for a redrawn patient sample. The kinetics of the measuring curve obtained at 21:38 using sample (b)(6) indicated a clear baseline, clotting and endpoint phase of the reaction. The kinetics of this measurement curve supports that the result for the affected sample was greater than the reportable limit of 139 seconds. This result aligns with the patient's unfractionated (uf) heparin therapy and the result obtained at the alternate facility. The patient was administered uf heparin with an iv and uf heparin is an anticoagulant that causes elevation of the activated partial thromboplastin time (aptt) results. If the patient is administered uf heparin therapy via an iv, the patient's blood must be collected such that the uf heparin infusion does not contaminate the sample. Siemens is unable to determine if the samples were collected correctly. However, the customer indicated that the affected samples were peripherally collected and the samples' integrity were acceptable. The same dade actin fsl activated ptt reagent lots were used on both systems, excluding a general issue with the system and reagent used. The cause of the flagged, non-numerical aptt results is unknown. The systems and reagent are performing according to specifications. No further evaluation of these systems or reagent is required.
Patient Sequence No: 1, Text Type: N, H10
[90861873]
A flagged, non-numerical activated partial thromboplastin time (aptt) result was obtained on a patient sample on the sysmex cs-5100 system. The patient sample was rerun with extended measurement time on the same system and a non-numerical, flagged result was obtained. The patient's blood was redrawn and run, in duplicate, on the same system and non-numerical flagged results were obtained. The redrawn patient sample was rerun on an alternate sysmex cs-2500 system, resulting in a non-numerical flagged result. The customer sent out the patient sample to an alternate lab, where the sample was rerun on a bcs xp system, resulting in an elevated aptt result. The customer reported this result as >200 seconds to the physician and the physician modified the patient's heparin therapy based on this result. The customer alleged that the delay in reporting of results from the sysmex cs-5100 system and sysmex cs-2500 system caused the patient that had undergone a percutaneous transluminal angioplasty procedure to bleed from his wound. The bleeding was stopped with applied pressure to the right groin for an hour. There are no known reports of patient intervention or adverse health consequences due to the delay in reporting of aptt results on the patient samples.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2017-00117 |
| MDR Report Key | 6973814 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-10-24 |
| Date of Report | 2017-10-24 |
| Date of Event | 2017-09-28 |
| Date Mfgr Received | 2017-09-29 |
| Date Added to Maude | 2017-10-24 |
| 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 | 2017-10-24 |
| Model Number | DADE ACTIN FSL ACTIVATED PTT REAGENT |
| Catalog Number | 10445714 |
| Lot Number | 556904 |
| Device Expiration Date | 2018-12-05 |
| 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 | 2017-10-24 |