MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH N LATEX FLC LAMBDA

Model Number N LATEX FLC LAMBDA

Device Problem High Test Results (2457)

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

Event Date 12/14/2018

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center and reported that discordant, falsely elevated free light chains (flc), type lambda (flc lambda) results were obtained on a patient sample on the bn prospec system.A siemens customer service engineer (cse) was dispatched to the customer's site and collected system files.Siemens reviewed the reaction kinetics for the affected results and found no issue; the reaction kinetics correlated to the results obtained on the sample.Siemens determined that the sample was diluted by the system (in a 1:20 dilution, 1:100 dilution, 1:400 dilution, and 1:2000 dilution) until numerical results were obtained; numerical results were obtained on the sample after the 1:2000 dilution.There was no indication of a system malfunction, and siemens determined that the cause of the discordant flc lambda results was sample specific; the n latex flc lambda instructions for use (ifu) indicates that: "patient samples may contain heterophilic antibodies that could react in immunoassays to give a falsely elevated or depressed result.This assay has been designed to minimize interference from heterophilic antibodies." the system is performing according to specifications.No further evaluation of this device is required.Mdr 9610806-2019-00006 was filed for the discordant flc lambda result obtained on (b)(6) 2018 and mdr 9610806-2019-00007 was filed for the discordant flc lambda result obtained on (b)(6) 2018.

Event Description

A discordant, falsely elevated free light chains (flc), type lambda (flc lambda) result was obtained on a patient sample on a bn prospec system.The discordant result was reported to the physician(s), who questioned the result.The sample was also tested for flc lambda using a non-siemens method, and a lower result was obtained on the sample.On (b)(6) 2018, the sample was repeated on the same system, resulting in another discordant, falsely elevated flc lambda result.The discordant results were not corrected.There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated flc lambda results.

Manufacturer Narrative

Additional information (21-dec-2018): a siemens customer service engineer (cse) was dispatched to the customer's site.During this visit, the cse: replaced and aligned a probe on the bn prospec system; adjusted the probe temperature, optics, and mixer in diluent tray; performed scs clean; verified that the mixer cuvette, wet system, and pumps were performing within specifications; verified that the temperature in cuvette and reagent rotor were within acceptable ranges, and aligned the darklight.The cse returned to the customer's site on (b)(6) 2018 and determined that the customer misplaced the water and diluent positions on the system, impacting the free light chains (flc), type lambda (flc lambda) recovery.The cse corrected the water and diluent positions on the system.The customer informed siemens that the affected sample was not available for further investigation and indicated that a new sample from the patient was obtained.The system is performing according to specifications.No further evaluation of this device is required.Mdr 9610806-2019-00006_s1 was filed for the same issue.

Manufacturer Narrative

Siemens filed the initial mdr 9610806-2019-00007 on 11-jan-2019, the first supplemental mdr on 16-jan-2019, and the second supplemental mdr on 12-feb-2019.Additional information (06-feb-2019): the customer reported that additional elevated free light chains (flc), type lambda (flc lambda) results were obtained on sample(s) from the patient and mdrs 9610806-2019-00011, 9610806-2019-00012, 9610806-2019-00013, and 9610806-2019-00014 were filed for the additional elevated flc lambda results.The system is performing according to specifications.No further evaluation of this device is required.Mdrs 9610806-2019-00006_s3, 9610806-2019-00008_s1, and 9610806-2019-00009_s1 were also filed for the same issue.

Manufacturer Narrative

Siemens filed the initial mdr 9610806-2019-00007 on 11-jan-2019 and the first supplemental mdr on 16-jan-2019.Additional information (14-jan-2019): the customer reported that elevated free light chains (flc), type lambda (flc lambda) results were obtained on two additional samples from the same patient.The customer provided one of the samples for further investigation.Siemens further investigated the issue and a study was performed on the affected sample.The sample was tested on a bn prospec system using the same reagent, and the flc lambda result confirmed the elevated recovery observed by the customer.Analysis of the sample portrayed that the flc lambda determinations were correctly evaluated by the bn prospec system; flc lambda concentration was present in a large protein complex in the sample.The system is performing according to specifications.No further evaluation of this device is required.Mdrs 9610806-2019-00008, 9610806-2019-00009, and 9610806-2019-00006_s2 were filed for the same issue.

Manufacturer Narrative

Siemens filed the initial mdr on 11-jan-2019, the first supplemental mdr on 16-jan-2019, the second supplemental mdr on 12-feb-2019, and the third supplemental mdr on 07-mar-2019.Additional information (21-jun-2019): the customer provided another sample from the patient for further investigation.It was determined that the sample was shipped under unacceptable conditions.Upon arrival, the sample was analyzed for free light chains (flc), type lambda (flc lambda) on a bn prospec system to evaluate whether the sample was acceptable for further investigation.The flc lambda concentration in the sample was 17,000 mg/l; compared to the flc concentrations in previous samples, the flc lambda concentration in this sample was higher and the sample was subjected to further testing.The investigation demonstrated that the sample did not contain elevated flc lambda concentrations and the result obtained on the bn prospec system was discordant, falsely elevated.In this unique sample, due to an unknown reason, the n latex flc lambda assay detected another molecule as flc lambda.This molecule, that was analyzed as flc lambda by the n latex flc lambda assay, was not identified during the investigation.This phenomenon is specific to this patient.Based on the additional information, the information from section d1, section d2, section d4, section g1,2 (continued), and section g5 were updated.Mdr 9610806-2019-00006_s4, mdr 9610806-2019-00008_s2, mdr 9610806-2019-00009_s3, mdr 9610806-2019-00011_s2, mdr 9610806-2019-00012_s2, mdr 9610806-2019-00013_s2, and mdr 9610806-2019-00014_s2 were filed for the same event.

• Brand Name: N LATEX FLC LAMBDA
• Type of Device: N LATEX FLC LAMBDA
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring- str. 76; marburg, D-350 41; GM D-35041
• MDR Report Key: 8239685
• MDR Text Key: 134494609
• Report Number: 9610806-2019-00007
• Device Sequence Number: 1
• Product Code: DEH
• UDI-Device Identifier: 00630414002736
• UDI-Public: 00630414002736
• Combination Product (y/n): N
• PMA/PMN Number: K182098
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/15/2019
• Device Model Number: N LATEX FLC LAMBDA
• Device Catalogue Number: 10482438
• Device Lot Number: 473242
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1