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

Model Number LA 1 SCREENING REAGENT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 02/24/2018

Event Type  malfunction  

Manufacturer Narrative

The customer contacted siemens and reported that they obtained a 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 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.A siemens headquarters support center (hsc) specialist contacted the customer to investigate the cause of the event.The customer reported that their lab has 4 bcs xp systems and independent reagent vials are loaded into each system.Siemens further reviewed the backup files and determined that quality controls recovered within expected ranges prior to running the affected patient samples on (b)(6)2018.Siemens determined that the samples were run with pooled vials of reagent, which gradually decreased with time (as expected).The error logs contained implausible volume detection errors, but the volume of the reagent and sample id (b)(6) were not impacted.Siemens determined that there was no indication of a system or reagent malfunction that contributed to the discordant, falsely elevated la 1 screening reagent clotting time result.The cause of the event is unknown.A siemens field service engineer (fse) was dispatched to the customer's site for rotor handler and rack transfer errors on 15-feb-2018.The hsc specialist determined that this service was unrelated to this event.The systems and reagent are performing according to specifications.No further evaluation of these systems and reagent is required.Mdr 9610806-2018-00032 and mdr 9610806-2018-00033 were filed for the same event.

Event 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 (serial number (sn) (b)(4)) using the la 1 screening reagent.Due to the elevated result, 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).The same sample was rerun on an alternate bcs xp system (sn (b)(4)), resulting in a lower la 1 screening reagent clotting time result.The sample was tested for la 2 confirmation reagent clotting time and a ratio was calculated from these results.The ratio of 0.9 was reported to the physician(s), indicating that the patient was negative for la and this was consistent with the patient's clinical picture.The sample was frozen and rerun on (b)(6) 2018 on an alternate bcs xp system (sn (b)(4)), resulting in a lower la 1 screening reagent clotting time result than the initial 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
• Type of Device: LA 1 SCREENING REAGENT
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring- str. 76; marburg, D-350 41; GM D-35041
• Manufacturer (Section G): DSRV, INC.; registration #: 3004737529; 330 waterloo valley rd ste 200; mount olive NJ 07828
• Manufacturer Contact: christina lam ; 511 benedict ave; tarrytown, NY 10591 ; 9145243504
• MDR Report Key: 7339663
• MDR Text Key: 102469321
• Report Number: 9610806-2018-00034
• Device Sequence Number: 1
• Product Code: GIR
• UDI-Device Identifier: 00842768007477
• UDI-Public: 00842768007477
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K922326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/28/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1