MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW DIMENSION SYSTEM; HEMOGLOBIN A1C KIT

Catalog Number DF105A SMN10483822

Device Problem Low Test Results (2458)

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

Event Date 08/29/2016

Event Type  malfunction  

Manufacturer Narrative

Analysis of the instrument and instrument data indicate that the cause for the falsely depressed hb1c results is user error.The account failed to properly reconstitute the hb1c calibrators that are included with the hb1c kit.The calibrator instructions for use direct the customer to reconstitute the calibrators with 2 ml of water but the customer reconstituted with only 1 ml.A calibration was performed with the under-reconstituted vials and patient results were reported before the out of range qc values were detected.The issue was resolved with a proper preparation of calibrators, a recalibration, and confirmation with qc.Corrected patient results were issued.The device is performing within specifications.No further evaluation of the device is required.

Event Description

Falsely depressed hb1c results were obtained on qc and patient samples on the dimension exl system.Patient results were reported to the physician who questioned the results.The samples were repeated after recalibration and higher results were obtained.There is no indication that patient treatment was altered or prescribed on the basis of the falsely depressed hb1c results.There was no report of adverse health consequences as a result of the falsely depressed hb1c results.

• Brand Name: DIMENSION SYSTEM
• Type of Device: HEMOGLOBIN A1C KIT
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW; glasgow business community; 500 gbc drive; newark DE 19714
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW; glasgow business community; 500 gbc drive; newark DE 19714
• Manufacturer Contact: james morgera ; glasgow business community; po box 6101; newark, DE 19714-6101 ; 3026318356
• MDR Report Key: 5973282
• MDR Text Key: 55469030
• Report Number: 2517506-2016-00327
• Device Sequence Number: 1
• Product Code: JJX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102510
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date: 09/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Technologist
• Device Catalogue Number: DF105A SMN10483822
• Device Lot Number: GC7055
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2016
• 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