MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH BCS XP SYSTEM

Model Number BCS XP SYSTEM

Device Problem Use of Device Problem (1670)

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

Event Date 07/25/2018

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center and reported that discordant results were obtained on an icteric sample on the bcs xp systems.Siemens reviewed the system files for the bcs xp system with serial number (sn) (b)(4) and determined that the bcs xp system with sn (b)(4) performed as intended; siemens determined that the sample had an absorbance that exceeded the photometer capability on the bcs xp system.The patient sample also contained a bilirubin value of >30 mg/dl, which exceeded the bilirubin interference limitation 12 mg/dl listed in the bcs xp system reference guide for multifibren u; the other coagulation test results also indicated that the sample was highly turbid.The cause of the discordant, falsely elevated fibrinogen results and imprecise pt % and pt inr results was potentially due to a sample specific issue.The systems are performing according to specifications.No further evaluation of these devices is required.Mdr 9610806-2018-00082 was filed for the discordant results obtained on the bcs xp system with sn (b)(4).

Event Description

The customer reported that a flagged fibrinogen result was obtained on a patient sample on the bcs xp system with serial number (sn) (b)(4) and was not transferred to the host.Due to this, the sample was repeated on the same system, resulting in a discordant, falsely elevated fibrinogen result.The discordant result was not reported to the physician(s).The same sample was repeated using the fibrinogen 570 and fibrinogen low 570 assays, resulting in a non-numerical result and an expected result for the patient.The sample was repeated for fibrinogen, fibrinogen 570 and fibrinogen low 570 on the bcs xp system with sn (b)(4), resulting in an elevated result, a non-numerical result and an expected result.The customer stated that the expected range for fibrinogen for this patient was between 50 and 100 mg/dl and did not indicate which results were reported to the physician(s).Additionally, imprecise prothrombin time (pt) % and pt international normalized ratio (inr) results were also obtained on the patient sample on the bcs xp system with sn (b)(4).The sample was also repeated on the bcs xp system with sn (b)(4) for pt % and pt inr, resulting lower for pt % and higher for pt inr than most pt results obtained on the bcs xp system with sn (b)(4).It is unknown whether any of the pt % or pt inr results was reported to the physician(s) and the correct results are unknown.There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated fibrinogen result and imprecise pt % and pt results.

• Brand Name: BCS XP SYSTEM
• Type of Device: BCS XP 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: 7802840
• MDR Text Key: 118116712
• Report Number: 9610806-2018-00083
• Device Sequence Number: 1
• Product Code: GKP
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K970431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BCS XP SYSTEM
• Device Catalogue Number: 11240019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2018
• 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