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 01/14/2019

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center and reported that a discordant free light chains (flc), type lambda (flc lambda) result was obtained on a patient sample on a bn prospec system.The customer previously contacted siemens regarding discordant flc lambda results obtained for this patient and mdrs 9610806-2019-00006 and 9610806-2019-00007 were filed for the discordant results previously obtained on the other samples from this patient.Siemens previously determined that there was no indication of a system malfunction and that the cause of the discordant flc lambda results was sample specific, but the customer did not have the sample for further investigation.The customer provided the affected sample for further investigation; siemens further investigated the issue and a study was performed on the affected sample.The sample was tested for flc lambda 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.Mdr 9610806-2019-00009 was filed for the elevated flc lambda result obtained on the week of 28-jan-2019 on another sample from the patient.Supplemental mdrs 9610806-2019-00006_s2 and 9610806-2019-00007_s2 were filed for the same issue.

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 not reported to the physician(s).The sample was also tested for flc lambda using a non-siemens method and the customer reported that a negative flc lambda result was obtained using the non-siemens method.The customer reported the negative flc lambda result to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated flc lambda result.

Manufacturer Narrative

Siemens filed the initial mdr 9610806-2019-00008 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, 9610806-2019-00007_s3, and 9610806-2019-00009_s1 were also filed for the same issue.

Manufacturer Narrative

Siemens filed the initial mdr 9610806-2019-00008 on 12-feb-2019 and the first 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 9610806-2019-00007_s4, 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: 8331431
• MDR Text Key: 139066784
• Report Number: 9610806-2019-00008
• 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
• Report Date: 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2019
• 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