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

Model Number N LATEX FLC LAMBDA

Device Problem Low Test Results (2458)

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

Event Date 07/02/2018

Event Type  malfunction  

Manufacturer Narrative

Siemens is investigating the issue.Mdr: 9610806-2018-00077 was filed for the discordant result obtained on the patient sample on the bn ii system in the middle of (b)(6).Mdr: 9610806-2018-00078 was filed for the discordant result mentioned that was obtained on (b)(6) 2018.

Event Description

A discordant, falsely low free light chains (flc), type lambda (flc lambda) result was obtained on a patient sample on a bn ii system.The discordant result was reported to the physician(s), who questioned the result.At the end of (b)(6) 2018, different samples from the patient were tested for flc lambda in two alternate laboratories, resulting higher than the initial result.The results obtained at the other laboratories were reported to the physician(s) and the highest result was considered to be the correct result.On (b)(6) 2018, the sample was diluted in a 1 to 10 dilution and repeated on the same bn ii system, resulting lower.The result obtained on the diluted sample was reported to the physician(s), who questioned the result.There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low flc lambda results.

Manufacturer Narrative

Additional information (27-jul-2018): on 02-jul-2018, another sample from the patient (sample id (b)(6)) was run for free light chains (flc), type lambda (flc lambda), flc, type kappa (flc kappa), and flc ratio.A discordant, falsely low flc lambda result was obtained on sample id (b)(6) and it is unknown if this result was reported to the physician(s).The customer provided sample id (b)(6) for further investigation.The sample was tested for flc lambda, flc kappa and flc ratio and the results recovered similar to the results obtained at the customer's site.The sample was treated with a substance to reduce the cysteine bonds in the light chain modules and repeated for flc lambda, flc kappa, and flc ratio; higher flc lambda and flc kappa results and a lower flc ratio result were obtained on the patient sample.Siemens investigated the instrument files and found no issue.Siemens determined that the calibration curves were valid and quality controls were within expected ranges on the day of the event.Based on the investigation, it was determined that by reducing the cysteine bonds, higher flc lambda recovery was detected in the dimer fractions in the sample; the folding of the lambda dimer prevented detection of the flc lambda using the n latex flc lambda reagent.The cause of the discordant, falsely low flc lambda results was potentially due to a sample specific issue.The reagent is performing according to specifications.No further evaluation of this device is required.Mdr 9610806-2018-00077_s1 and mdr 9610806-2018-00078_s1 were filed for the same event.

Event Description

On 02-july-2018, another sample from the same patient (sample id (b)(6)) was run for free light chains (flc), type lambda (flc lambda), flc, type kappa (flc kappa), and flc ratio.A discordant, falsely low flc lambda result was obtained on sample id (b)(6) and it is unknown if this result was reported to the physician(s).

• 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: 7726156
• MDR Text Key: 115531443
• Report Number: 9610806-2018-00079
• Device Sequence Number: 1
• Product Code: DEH
• Combination Product (y/n): N
• PMA/PMN Number: K171742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 08/28/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 11/09/2018
• Device Model Number: N LATEX FLC LAMBDA
• Device Catalogue Number: 10482438
• Device Lot Number: 473241
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/02/2018
• Initial Date FDA Received: 07/27/2018
• Supplement Dates Manufacturer Received: 07/27/2018
• Supplement Dates FDA Received: 08/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR