MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION EXL 200; CLINICAL CHEMISTRY ANALYZER

Model Number DIMENSION EXL 200

Device Problem Device Handling Problem (3265)

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

Event Date 07/24/2018

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc).The ccc specialist reviewed instrument data and confirmed the hcg quality control (qc) recovery was within acceptable ranges at the time of the event.The probe tip cycles and heterogeneous module (hm) maintenance was reviewed, and the ccc specialist provided instructions to replace and align the sample and reagent arm 1 (r1) probe tips, hm pump heads and stylette the hm wash probes.The customer performed a successful system check and was instructed to run hcg qc and repeat the patient sample.The qc results were within acceptable ranges, and the patient sample ran 5 replicates, and produced results (<1.0 miu/ml) that correlate with the alternate instrument.The cause of the falsely elevated result is unknown.The instrument is performing within specifications.No further evaluation of the device is required.

Event Description

A discordant falsely elevated human chorionic gonadotropin (hcg) result was obtained on a dimension exl 200 instrument.The initial result was reported to the physician(s).The customer used the same patient sample and an alternate instrument to perform repeat testing.The repeated result was lower, and a corrected report was issued.There are no reports of patient intervention or adverse health consequence due to the discordant, falsely elevated hcg result.

• Brand Name: DIMENSION EXL 200
• Type of Device: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 101 silvermine road; registration #: 1226181; brookfield CT 06804
• Manufacturer Contact: rolando hualpa ; 511 benedict ave; tarrytown, NY 10591 ; 9145242963
• MDR Report Key: 7793629
• MDR Text Key: 117587754
• Report Number: 2517506-2018-00462
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 00630414593579
• UDI-Public: 00630414593579
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073604
• 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: 08/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIMENSION EXL 200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/23/2014
• 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