MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH MULTIFIBRIN U

Catalog Number OWZG

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/25/2015

Event Type  malfunction  

Event Description

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.

Manufacturer Narrative

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.

• Brand Name: MULTIFIBRIN U
• Type of Device: MULTIFIBRIN U
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; 76 emil von behring strasse; marburg, 3504 1; GM 35041
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; 76 emil von behring strasse; marburg, 3504 1; GM 35041
• Manufacturer Contact: james morgera ; glasgow business community; po box 6101; newark, DE 19714-6101 ; 3026318356
• MDR Report Key: 4856067
• MDR Text Key: 5852356
• Report Number: 9610806-2015-00013
• Device Sequence Number: 1
• Product Code: KQJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K934326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date: 05/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Technologist
• Device Catalogue Number: OWZG
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other