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

Model Number DIMENSION EXL WITH LM

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

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

Event Date 04/03/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc) and stated that their quality controls were within acceptable range.The customer also stated that they did not get any flag on the patient sample, however, they had obtained abnormal assay flag on hemolysis, icterus and lipemia interference.A siemens headquarters support center (hsc) specialist reviewed the instrument.The hsc specialist recommended that the customer replace the source lamp, as two filter reading were above the recommended ranges.The filters are not likely related the hcg issue.The hsc specialist concluded that the issue may have been due to a specimen integrity issue affecting the sampling of the original result, the tube or cup being removed after a level sense and before sampling to process another test, or processing of the wrong sample.The cause of the discordant, falsely low hcg result on one patient sample is unknown.The instrument is performing within specifications.No further evaluation of device is required.

Event Description

A discordant, falsely low human chorionic gonadotropin (hcg) result was obtained on one patient sample on a dimension exl with lm instrument.The discordant result was reported to the physician(s), who questioned it.The sample was repeated on the same instrument, resulting higher.The corrected result was reported to the physician(s).There are no reports of patient intervention or adverse health consequence due to the discordant, falsely low hcg result.

• Brand Name: DIMENSION EXL WITH LM
• 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: margarita karan ; 511 benedict ave; tarrytown, NY 10591 ; 9145243105
• MDR Report Key: 6539911
• MDR Text Key: 74364948
• Report Number: 2517506-2017-00462
• Device Sequence Number: 0
• Product Code: DHA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130276
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIMENSION EXL WITH LM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/24/2013
• 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