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

Catalog Number	10444972
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/19/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: ENZYMATIC CARBONATE FLEX REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• MDR Report Key: 7782805
• Report Number: 2517506-2018-00453
• Device Sequence Number: 1392319
• Product Code: KHS
• UDI-Device Identifier: 00842768005374
• UDI-Public: 00842768005374
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K010206
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 05/02/2019
• Device Catalogue Number: 10444972
• Device Lot Number: EB9122
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/19/2018
• Initial Report FDA Received Date: 08/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1