MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH LA 1 SCREENING REAGENT

Model Number	LA 1 SCREENING REAGENT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A siemens headquarters support center (hsc) specialist contacted the customer to investigate the cause of the discordant, falsely elevated lupus anticoagulants (la) 1 screening reagent clotting time patient result on a bcs xp system using the la 1 screening reagent.The customer did not observe any system flag when the discordant result was obtained.The customer received 5 sample tubes from this patient and was not able to correlate the result to a specific sample collection tube and time.The customer reported that they receive frozen samples.Upon receipt, the customer thaws the samples in a 37 degrees water bath for 5-10 minutes prior to placing it on a rocker.The sample is then rocked for 5-20 minutes.The customer also reported that they conduct a medical review of abnormal results by comparing the abnormal result to results obtained on other parameters for the patient.The hsc specialist was not able to identify the data for this patient in the system's backup files.The hsc specialist determined that the cause of the discordant, falsely elevated la 1 screening reagent clotting time result was potentially due to a sample handling or collection issue.The cause of the discordant result on this patient cannot be determined since the customer did not want to further investigate this sample.The systems and reagent are performing according to specifications.No further evaluation of these systems and reagent is required.Mdr 9610806-2018-00033 and mdr 9610806-2018-00034 were filed for the same event.
Event or Problem Description
A discordant, falsely elevated lupus anticoagulants (la) 1 screening reagent clotting time result was obtained on a patient sample on a bcs xp system using the la 1 screening reagent.Due to this, the sample was tested for la 2 confirmation reagent clotting time and a ratio was calculated from these results.Based on the lab's ranges, the ratio signified that the patient was positive for la.None of these results were reported to the physician(s).A sample from the same patient was run on an alternate bcs xp system and lower la 1 screening reagent clotting time and la 2 confirmation clotting time results were obtained on the patient sample.It is unknown if the initial results and repeat results were obtained using the same sample.The result of 39.3 seconds was reported to the physician(s), who did not question the result.There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated la 1 screening reagent clotting time result.

• Brand Name: LA 1 SCREENING REAGENT
• Common Device Name: LA 1 SCREENING REAGENT
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring- str. 76; marburg, D-350 41; GM D-35041
• MDR Report Key: 7339668
• Report Number: 9610806-2018-00032
• Device Sequence Number: 13600831
• Product Code: GIR
• UDI-Device Identifier: 00842768007477
• UDI-Public: 00842768007477
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K922326
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 03/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/10/2018
• Device Model Number: LA 1 SCREENING REAGENT
• Device Catalogue Number: 10461887
• Device Lot Number: 549936A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/15/2018
• Initial Report FDA Received Date: 03/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1