MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION RXL MAX WITH HM; CLINICAL CHEMISTRY ANALYZER

Model Number DIMENSION RXL MAX WITH HM

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

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

Event Date 03/10/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc) specialist.The customer stated that the instrument maintenance and reagent stability were acceptable.A siemens headquarters support center (hsc) specialist reviewed the instrument data.The hsc specialist stated the discordant result may have been due to a mislabeled sample.The cause of the discordant, falsely elevated hcg result on one patient sample is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

A discordant, falsely elevated human chorionic gonadotropin (hcg) result was obtained on one patient sample on a dimension rxl max with hm instrument.The discordant result was reported to the physician(s), who questioned it.A new sample was obtained from the patient and was tested on the same instrument, resulting lower.The customer then repeated the original sample twice on the same instrument, also resulting lower.The corrected results were reported to the physician(s).There are no reports of patient intervention or adverse health consequence due to the discordant, falsely elevated hcg result.

• Brand Name: DIMENSION RXL MAX WITH HM
• 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.; registration #: 1226181; 101 silvermine road; brookfield CT 06804
• Manufacturer Contact: cassandra kocsis ; 511 benedict ave; tarrytown, NY 10591 ; 9145242687
• MDR Report Key: 6461361
• MDR Text Key: 71837508
• Report Number: 2517506-2017-00339
• Device Sequence Number: 0
• Product Code: DHA
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K112999
• 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: 04/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIMENSION RXL MAX WITH HM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2017
• Initial Date FDA Received: 04/05/2017
• 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