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 02/13/2018

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 and determined that preventive maintenance (pm) is performed as required and up to date for both systems.The customer reported that their lab has 4 bcs xp systems and independent reagent vials are loaded into each system.A discordant result was obtained on a specific sample aliquot, which potentially contained small bubbles or foam that may have led to inadequate sample aspiration.The hsc specialist determined that inadequate sample aspiration and the use of different reagent vials and systems, utilized to test the same sample, potentially contributed to the different results obtained on the patient sample.The sample was repeated within 2.5 hours and while the customer has validated the stability of 8 hours for thawed samples for la assays, this has not been confirmed by siemens.The hsc specialist determined that the results from the other screening tests (aptt and factor viii) generally reflects that the patient was not under anticoagulants.The hsc specialist determined there is no indication of a system malfunction, medication interference or poor blood collection process.The hsc specialist also determined that the customer used siemens application as base assays.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 cause of the event is unknown.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 9610806-2018-00034 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 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, resulting in a lower la 1 screening reagent clotting time result.The sample was also tested for la 2 confirmation reagent clotting time and a ratio was calculated from these results.The ratio signified that the patient was weakly positive for la.Since the patient's activated partial thromboplastin time (aptt) and factor viii results recovered within normal ranges, a la ratio of 1.3 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
• 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: 7339667
• MDR Text Key: 102864187
• Report Number: 9610806-2018-00033
• 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: 02/15/2018
• 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