MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ENZYMATIC CARBONATE FLEX REAGENT CARTRIDGE

Catalog Number 10444972

Device Problem High Test Results (2457)

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

Event Date 07/19/2018

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc) and reported that reagent arm 1 probe and reagent lot were replaced on the dimension exl 200 instrument due to the discordant eco2 results.The customer reported that after replacing the reagent and probe, calibration and quality controls (qcs) were acceptable.The customer indicated that the reagent used in initial testing was compromised, and resolved the issue by replacing the reagent.A siemens customer service engineer (cse) was dispatched to the customer site to collect data for further analysis.Siemens further analyzed the instrument files and determined that qc was within range and there were no additional discordant results obtained on the instrument using the enzymatic carbonate flex reagent cartridge.The cause of the discordant, falsely elevated eco2 results is unknown.The instrument and reagent are operating within manufacturing specifications.No further evaluation of the device is required.

Event Description

Discordant, falsely elevated enzymatic carbonate (eco2) results were obtained on three patient samples on a dimension exl 200 instrument using the enzymatic carbonate flex reagent cartridge lot eb9122.The customer replaced reagent arm 1 probe and repeated two samples, resulting in two discordant, falsely elevated eco2 results.The discordant results were not reported to the physician(s).Using a new reagent from lot eb9122, the samples were repeated on the same instrument, resulting lower.The 2nd repeat results were reported, as the correct results, to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant, falsely elevated eco2 results.

• Brand Name: ENZYMATIC CARBONATE FLEX REAGENT CARTRIDGE
• Type of Device: ENZYMATIC CARBONATE FLEX REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEATLHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer Contact: anu prasad ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242530
• MDR Report Key: 7782805
• MDR Text Key: 117446512
• Report Number: 2517506-2018-00453
• Device Sequence Number: 1
• Product Code: KHS
• UDI-Device Identifier: 00842768005374
• UDI-Public: 00842768005374
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K010206
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/14/2018

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: 05/02/2019
• Device Catalogue Number: 10444972
• Device Lot Number: EB9122
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/19/2018
• Initial Date FDA Received: 08/14/2018
• 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