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 2018-04-09 for INNOVANCE HEPARIN 10873535 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[105277559]
Siemens healthcare diagnostics has investigated the provided information to determine the cause of the discordant, low heparin patient sample result on the bcs xp analyzer. No product non-conformance could be identified and a possible cause of the event may be sample specific or related to sample handling. Siemens requested a backup file and clarification of the type of heparin administered, but the customer declined to provide further information and stated that they have had no further issues with other samples. The instrument and reagent are performing according to specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
[105277560]
A discordant, low heparin patient result (0. 02 iu/ml) using innovance heparin kit lot 47758 was generated on the bcs xp analyzer. This patient result was not reported to the physician. The same patient sample was remixed and recentrifuged on the same day and run on the same bcs xp analyzer. A higher heparin patient result of 0. 44 iu/ml (repeat result 1) was generated, but not reported to the physician. The same sample was repeated again on the same bcs xp analyzer and a heparin patient result of 0. 45 iu/ml (repeat result 2) was generated and reported to the physician. The repeat heparin results matched the clinical expectation of the patient. Quality control values were within range before testing. There was no known impact or adverse health consequence to the patient due to the low innovance heparin result as the result was not reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2018-00040 |
| MDR Report Key | 7409215 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-04-09 |
| Date of Report | 2018-04-09 |
| Date of Event | 2018-03-14 |
| Date Mfgr Received | 2018-03-14 |
| Device Manufacturer Date | 2017-09-15 |
| Date Added to Maude | 2018-04-09 |
| 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 | 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 | INNOVANCE HEPARIN |
| Generic Name | INNOVANCE HEPARIN |
| Product Code | KFF |
| Date Received | 2018-04-09 |
| Catalog Number | 10873535 |
| Lot Number | 47758 |
| Device Expiration Date | 2019-05-03 |
| 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 STRASSE 76 MARBURG, GM 35041 GM 35041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-09 |