MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-06-19 for MULTIFIBRIN U OWZG manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[5852356]
A falsely depressed, flagged fibrinogen result was obtained on a patient sample. The depressed, flagged patient result was reported to the physicians who eventually questioned the result. The repeat test of the sample provided a higher result in the normal reference range. Patient treatment was altered or prescribed on the basis of the falsely depressed fibrinogen result. Fresh frozen plasma and cryoprecipitate were administered before the physician questioned the result. The patient experienced a thrombotic event. They patient was further treated to reverse the effects of the cryoprecipitate treatment. The account has noted that the patient is ok after that treatment.
Patient Sequence No: 1, Text Type: D, B5
[13474546]
The cause of the discrepant falsely depressed fibrinogen result is a known susceptibility of the multifibrin u reagent. The falsely depressed level appears to be related to the patient's medication. The sample result was accompanied by the comment "results doubtful" and the analyzer operated as intended. Per the bcs xp operator's guide this comment flag does not preclude result reporting but would alert the operator to investigate further. The patient is on argatroban therapy, which can lead to falsely depressed fibrinogen levels. Argatroban is a direct thrombin inhibitor. Multifibrin u reagent contains bovine thrombin. The principle of the fibrinogen with mfu assay is " citrated plasma is brought to coagulation by a large excess of thrombin. " incorporating a medication that is intended to inhibit the function of thrombin can lead to interference in these assays. Documented in the multifibrin u instructions for use, limitations of the procedure section is the statement: "therapy with direct thrombin inhibitors, e. G. Hirudin, may contribute to diminished recovery. " the device is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610806-2015-00013 |
| MDR Report Key | 4856067 |
| Report Source | 05,06 |
| Date Received | 2015-06-19 |
| Date of Report | 2015-05-26 |
| Date of Event | 2015-05-25 |
| Date Mfgr Received | 2015-05-26 |
| Date Added to Maude | 2015-07-16 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JAMES MORGERA |
| Manufacturer Street | GLASGOW BUSINESS COMMUNITY PO BOX 6101 |
| Manufacturer City | NEWARK DE 197146101 |
| Manufacturer Country | US |
| Manufacturer Postal | 197146101 |
| Manufacturer Phone | 3026318356 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| Manufacturer Street | 76 EMIL VON BEHRING STRASSE |
| Manufacturer City | MARBURG, 35041 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 35041 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MULTIFIBRIN U |
| Generic Name | MULTIFIBRIN U |
| Product Code | KQJ |
| Date Received | 2015-06-19 |
| Catalog Number | OWZG |
| Lot Number | NOT PROVIDED |
| Operator | MEDICAL TECHNOLOGIST |
| 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 | 76 EMIL VON BEHRING STRASSE MARBURG, 35041 GM 35041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-06-19 |