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 2018-05-09 for BERICHROM HEPARIN 10446620 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[108249937]
The customer contacted siemens customer care center (ccc) and reported that discordant, falsely low heparin unfractionated results were obtained on 2 patient samples using the berichrom heparin reagent. The customer reported that these samples were run before it was time to run quality controls (qcs) and that two other patient samples were processed prior to the affected patient samples without issues. The customer reported that they ran qcs and the affected patient samples after they replaced the reagents with fresh reagents; the qcs and patient results recovered as expected. Siemens is investigating the issue.
Patient Sequence No: 1, Text Type: N, H10
[108249938]
Discordant, falsely low heparin unfractionated (uf) results were obtained on two patient samples on the bcs xp system using the berichrom heparin reagent. These results were autoverified by the system and sent to the hospital's laboratory information system (lis). The customer noticed that these results were discordant before they were reported to the physician(s). The customer replaced the reagents with fresh reagents and reran the samples; the repeat results were higher than the initial results and were reported, as the correct results, to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low heparin uf results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2018-00046 |
| MDR Report Key | 7500805 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-05-09 |
| Date of Report | 2018-06-01 |
| Date of Event | 2018-04-14 |
| Date Mfgr Received | 2018-05-09 |
| Date Added to Maude | 2018-05-09 |
| 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 | 2018-05-09 |
| Model Number | BERICHROM HEPARIN |
| Catalog Number | 10446620 |
| Lot Number | 47855 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2018-05-09 |