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 2017-10-23 for BERICHROM HEPARIN 10446620 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[90717159]
A siemens healthcare diagnostics inc. (siemens) customer service engineer (cse) was dispatched to the customer's site to determine the cause of the discordant, falsely low heparin unfractionated (uf) results. The cse performed sample probe and reagent probe alignments and tested both probes for accurate pipetting. The cse ran and repeated 10 previously affected patient samples with no issues. The cse indicated that results recovered within precision and accuracy specifications and that internal quality controls recovered close to the mean. The cause of the discordant, falsely low heparin uf results is unknown. The system and reagent are performing according to specifications. No further evaluation of this system or reagent is required.
Patient Sequence No: 1, Text Type: N, H10
[90717160]
Discordant, falsely low heparin unfractionated (uf) results were obtained on a patient sample on the bcs xp system. It is unknown whether all of the discordant results were flagged by the system. These results were not reported to the physician. The customer indicated that they reran the same sample on the same instrument until they obtained a result that matched the patient's clinical history. The repeated results recovered higher and the customer reported the highest flagged result to the physician. There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low heparin results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2017-00118 |
| MDR Report Key | 6970286 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-10-23 |
| Date of Report | 2017-10-23 |
| Date of Event | 2017-09-25 |
| Date Mfgr Received | 2017-09-25 |
| Date Added to Maude | 2017-10-23 |
| 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 | 2017-10-23 |
| Model Number | BERICHROM HEPARIN |
| Catalog Number | 10446620 |
| Lot Number | 46909 |
| Device Expiration Date | 2019-10-26 |
| 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 | 2017-10-23 |