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 2018-01-02 for BERICHROM HEPARIN 10446620 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[96619906]
On 21-nov-2017, a siemens healthcare diagnostics (siemens) customer service engineer (cse) was dispatched to the customer site and performed a preventative maintenance on the sysmex ca-1500 system. The operator declined further investigation and since (b)(6) 2017, the operator discontinued running the heparin unfractionated (uf) assay. Since the operator refused further investigation, siemens healthcare diagnostics (siemens) cannot determine the cause of the discordant, falsely low heparin uf result. No further evaluation of this device or reagent is required.
Patient Sequence No: 1, Text Type: N, H10
[96619907]
A discordant, falsely low heparin unfractionated (uf) result was obtained on a patient sample on the sysmex ca-1500 system. This result was reported to the physician, who did not question the result. The sample was sent to alternate facility and tested for heparin uf. An expected, higher heparin uf result was obtained on the patient sample. A corrected report was not provided for this patient. The patient's heparin treatment was not adjusted due to the discordant result. There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low heparin uf result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2018-00001 |
| MDR Report Key | 7158642 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-01-02 |
| Date of Report | 2018-01-02 |
| Date of Event | 2017-12-07 |
| Date Mfgr Received | 2017-12-07 |
| Date Added to Maude | 2018-01-02 |
| 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 |
| 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 | BERICHROM HEPARIN |
| Generic Name | BERICHROM HEPARIN |
| Product Code | KFF |
| Date Received | 2018-01-02 |
| Model Number | BERICHROM HEPARIN |
| Catalog Number | 10446620 |
| Lot Number | 47293 |
| 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 | 2018-01-02 |