MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW DIMENSION®; DIMENSION®CHEM I CALIBRATOR CHEMISTRY I CALIBRATOR

Catalog Number	DC18C SMN10716280
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis of the calibration data for (b)(4) performed by the customer care center (ccc) indicate the cause for the biased low glucose results is user error due to under-reconstitution of the calibrator prior to acceptance of the bad calibration.Quality control (qc) was outside acceptable limits after the calibration was manually accepted.The customer recalibrated another lot of glucose (glu) using a correctly reconstituted new set of calibrator.Qc recovered within laboratory ranges and the issue was resolved.The device is performing within specifications.No further evaluation of the device is required.
Event or Problem Description
Discordant falsely low glucose (glu) results were obtained on the dimension xpand plus.Biased low results were obtained while the customer accepted a bad calibration due to under-reconstitution of the calibrator.One initial result was reported to the physician for patient sample identification (b)(6) and not questioned.No other patient results were reported and a corrected report was issued for the initial result reported.There are no reports of patient intervention or adverse health consequences due to the discordant, falsely low glucose results.

• Brand Name: DIMENSION®
• Common Device Name: DIMENSION®CHEM I CALIBRATOR CHEMISTRY I CALIBRATOR
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW; glasgow business community; 500 gbc drive po box 6101; newark DE 19714 6101
• MDR Report Key: 6851958
• Report Number: 2517506-2017-00671
• Device Sequence Number: 13564048
• Product Code: JIT
• UDI-Device Identifier: 00630414948492
• UDI-Public: 00630414948492
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K860021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 09/08/2017

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: 05/01/2018
• Device Catalogue Number: DC18C SMN10716280
• Device Lot Number: 7DD066
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2017
• Initial Report FDA Received Date: 09/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1