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 2017-03-10 for BERICHROM HEPARIN 10446620 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[69576027]
The customer contacted the siemens customer care center regarding the incorrectly reported heparin patient result from the laboratory information system (lis). The customer confirmed the lis decimal format was configured incorrectly. The lis decimal format was corrected by the customer. The operator then recalibrated the system and re-ran the same sample on the same system (ca-1500 coagulation analyzer) 4-5 hours later. The cause of the discordant high heparin result on one patient sample was user error. The instrument is performing according to specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
[69576028]
A discordant high heparin result was reported to the physician. The initial heparin patient result generated on the ca-1500 coagulation analyzer (instrument) was 0. 09 iu/ml. The lis (laboratory information system) setting was not configured correctly and the lis reported the initial result of 0. 09iu/ml, as 0. 90 iu/ml. 0. 90iu/ml was reported to the physician. The physician did not question the result and stopped patient heparin treatment. The correct (initial) result of 0. 09 iu/ml was reported to the physician one hour later. Once the lis was configured correctly, the operator recalibrated the system and re-ran the same sample on the same system (ca-1500 coagulation analyzer) 4-5 hours later. The patient heparin result (repeat 1) generated was 0. 13 iu/ml which was reported to the physician and questioned. Patient was redrawn for a new sample and tested on the same system (ca-1500 coagulation analyzer) generating a repeat 2 heparin result of 0. 12 iu/ml which was also reported to the physician. The correct (initial) result of 0. 09 iu/ml was reported to the physician one hour later. There was no known impact or adverse health consequence to the patient due to the cessation of heparin treatment.
Patient Sequence No: 1, Text Type: D, B5
[73683383]
Siemens healthcare diagnostics inc. Filed the initial mdr 9610806-2017-00037 on 3/10/2017. On 3/29/2017-corrected information: siemens healthcare diagnostics inc. (siemens) has provided the corrected brand name and common device name as berichrom heparin.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610806-2017-00037 |
| MDR Report Key | 6394599 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-03-10 |
| Date of Report | 2017-04-03 |
| Date of Event | 2017-02-23 |
| Date Mfgr Received | 2017-03-29 |
| Device Manufacturer Date | 2015-03-06 |
| Date Added to Maude | 2017-03-10 |
| 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 | LORIANN RUSSO |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242287 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| Manufacturer Street | EMIL VON BEHRING STRASSE 76 |
| Manufacturer City | MARBURG, GM 35041 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 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 | 2017-03-10 |
| Catalog Number | 10446620 |
| Lot Number | 44808 |
| Device Expiration Date | 2018-01-06 |
| 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 STRASSE 76 MARBURG, GM 35041 GM 35041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-10 |