MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CHEMISTRY CREATININE REAGENTS, CONCENTRATED; ADVIA CHEMISTRY CREATININE REAGENTS, CONCENTRATED (CRE_2C)

Model Number ADVIA CHEMISTRY CREATININE REAGENTS, CONCENTRATED (CRE_2C)

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

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

Event Date 10/27/2015

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc) specialist.The customer found that quality controls were deviating low after the system switched reagent packs.A siemens headquarters support center (hsc) specialist reviewed the data and determined that the customer did not have auto-calibration and auto-qc enabled and that the customer had not blanked and calibrated the system after the reagent pack switch, causing a bias in the results.Upon the hsc specialist's recommendation, the customer blanked and calibrated the new reagent pack, after which patient data and qc recovery returned to normal.In addition, the customer has set up auto-calibration to run a reagent blank (rbl) and quality control, whenever an automatic reagent pack switch occurs.The cause of the discordant, falsely low crea_2c results on multiple patient samples was related to the incorrect adjustment of rbl and calibration on a new reagent pack.(b)(4).

Event Description

Discordant, falsely low concentrated creatinine (crea_2c) results were obtained on multiple patient samples on an advia 2400 instrument, using a reagent lot 338209.The discordant results were not reported to the physician(s).The samples were repeated on the same instrument, resulting lower than the initial results.The repeat results were reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant, falsely low crea_2c results.

• Brand Name: ADVIA CHEMISTRY CREATININE REAGENTS, CONCENTRATED
• Type of Device: ADVIA CHEMISTRY CREATININE REAGENTS, CONCENTRATED (CRE_2C)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10522
• Manufacturer (Section G): RANDOX LABORATORIES LTD. (REGISTRATION # 8020890); 55 diamond road; crumlin; co. antrim, BT29 4QY; UK BT29 4QY
• Manufacturer Contact: aziz aarti ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242683
• MDR Report Key: 5231277
• MDR Text Key: 31451955
• Report Number: 2432235-2015-00538
• Device Sequence Number: 1
• Product Code: CGX
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K991576
• 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: 10/28/2015

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: ADVIA CHEMISTRY CREATININE REAGENTS, CONCENTRATED (CRE_2C)
• Device Lot Number: 338209
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/28/2015
• Initial Date FDA Received: 11/17/2015
• 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