MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH BN II SYSTEM

Model Number BN II SYSTEM

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

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

Event Date 11/29/2017

Event Type  malfunction  

Manufacturer Narrative

A siemens healthcare diagnostics (siemens) field service engineer (fse) was previously dispatched to the operator's site on 21-nov-2017 and 10-aug-2017 and on 21-nov-2017, the fse replaced the "bn2 probe modul - rohs" on the bn ii system.The operator indicated that on (b)(6)2017, unexpected results were obtained at different dilutions for sample (b)(6) and the operator sent the affected sample for further investigation.Siemens calibrated a calibration curve using the affected n flc kappa (lot 473137) lot and n flc lambda (lot 473237) in combination with n flc supplementary reagent (kit-lot 47569) and n flc standard sl (lot 473434) on a bn ii system.Siemens ran quality controls (qcs) (n flc control sl1 and n flc control sl2) three times.The calibration curve and qcs recovered within expected ranges.Then, siemens tested the affected patient sample, in two fold determinations, using multiple dilutions (1:100, 1:400, 1:2000, and 1:8000) for both assays (free light chains (flc), type kappa and flc, type lambda).An average flc, type kappa result of 53.3 mg/l was obtained using the 1:100 dilution, an average flc, type kappa result of 71.1 mg/l was obtained using the 1:400 dilution, an average flc, type kappa result of <66.6 mg/l was obtained using the 1:2000 dilution and an average flc, type kappa result of <266 mg/l was obtained using the 1:8000 dilution on the affected sample.An average flc, type lambda result of 10.4 mg/l was obtained using the 1:20 dilution, an average flc, type lambda result of 10.7 mg/l was obtained using the 1:100 dilution, an average flc, type lambda result of <41.8 mg/l was obtained using the 1:400 dilution and an average flc, type lambda result of <209 mg/l was obtained using the 1:2000 dilution on the affected sample.Siemens was not able to confirm the discordant flc, type kappa results on the patient sample.The cause of the event is unknown.The system and reagent are performing according to specifications.No further evaluation of this system is required.

Event Description

On (b)(6) 2017, free light chains (flc), type kappa results of >107.00 mg/l were obtained on six patient samples on the bn ii system.The same samples were rerun using a higher dilution and the results for most samples recovered lower than the initial results.Sample (b)(6) recovered higher than the initial results and were rerun using higher dilution(s).The operator indicated that a discordant, falsely elevated flc, type kappa result was obtained on (b)(6).The operator indicated that no discordant flc, type kappa results were reported to the physician(s).On (b)(6) 2017, (b)(6) were also tested for flc, type lambda.It is unknown if any of the flc, type lambda results were reported to the physician(s).On (b)(6) 2017, the same samples were tested for flc, type kappa and flc, type lambda on the same system and different flc, type kappa results were obtained on the patient samples.The correct flc, type kappa result for (b)(6) is 53.9 mg/l and a corrected report was not issued to the physician.The correct results for the other patient samples is unknown and it is unknown if the results for the other patients were reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated flc, type kappa results.

• Brand Name: BN II SYSTEM
• Type of Device: BN II SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring- str. 76; marburg, D-350 41; GM D-35041
• Manufacturer (Section G): BIT ANALYTICAL INSTRUMENTS GMBH; am kronberger hang 3; registration number:3003601075; schwalbach, 65824 ; GM 65824
• Manufacturer Contact: christina lam ; 511 benedict ave; tarrytown, NY 10591 ; 9145243504
• MDR Report Key: 7158643
• MDR Text Key: 97067949
• Report Number: 9610806-2018-00002
• Device Sequence Number: 1
• Product Code: DEW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K943997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/02/2018

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 Model Number: BN II SYSTEM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/04/2017
• Initial Date FDA Received: 01/02/2018
• 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