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 2018-02-01 for BERICHROM HEPARIN 10446620 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[98996655]
On 10-jan-2018, a siemens healthcare diagnostics (siemens) customer service engineer (cse) was dispatched to the operator's site to determine the cause of different heparin unfractionated (uf) results obtained on a different patient on the bcs xp system. The operator replaced the standard human plasma (shp) calibrator and established a new calibration curve on (b)(6) 2018 and indicated that acceptable results were obtained using the new calibration curve. On 18-jan-2018, the operator indicated that different heparin uf results were obtained using the user defined method (udm) compared to the siemens' application of berichrom heparin reagent for two patient samples on (b)(6) 2018. Siemens obtained the assay procedure and definitions for the udm (assay procedure number 7021) and the siemens' application (assay procedure number 93) of the berichrom heparin reagent. Siemens reviewed the calibration curves that were established on (b)(6) 2017 and (b)(6) 2018 and determined that the assay procedures were acceptable. Siemens determined that the quality controls (qcs) and the calibration curve for assay procedure number 93 were within expected ranges. Siemens determined that assay procedure number 7021 is linked to the curve established for assay procedure number 93 and the last two points of the calibration curve is flat, which potentially contributed to some low raw value recovery for assay procedure number 7021. This potentially contributed to the different heparin uf results obtained using assay procedure number 7021. Siemens determined that assay procedure number 93 is performing within specifications. The cause of the event is unknown. The system and reagent are performing according to specifications. Mdr 9610806-2018-00021 was filed for the same event.
Patient Sequence No: 1, Text Type: N, H10
[98996656]
Heparin unfractionated (uf) results, flagged with "results above measurement range", were obtained on 2 patient samples on the bcs xp system, using the berichrom heparin reagent. The same samples were rerun, using a user defined method (udm) of the berichrom heparin reagent, on the same system, resulting lower. Sample 822 was manually diluted with standard human plasma (shp) and run using the siemens' application of the berichrom heparin reagent, resulting higher than the repeat result. The result obtained using the manual dilution was not reported to the physician(s). The operator indicated that the patient of sample 822 was potentially redrawn and run at an alternate lab, recovering in a result of 0. 91 iu/ml. The operator indicated that the expected results for these patients are unknown and that no corrected report was required since they did not report any discordant result. There are no known reports of patient intervention or adverse health consequences due to the different heparin uf results obtained on these samples.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2018-00022 |
| MDR Report Key | 7234639 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-02-01 |
| Date of Report | 2018-02-01 |
| Date of Event | 2018-01-16 |
| Date Mfgr Received | 2018-01-18 |
| Date Added to Maude | 2018-02-01 |
| 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 | 2018-02-01 |
| Model Number | BERICHROM HEPARIN |
| Catalog Number | 10446620 |
| Lot Number | 47486 |
| 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 | 2018-02-01 |