MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW DIMENSION(R) CLINICAL CHEMISTRY SYSTEM; HEMOGLOBIN A1C KIT

Catalog Number DF105

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/15/2015

Event Type  malfunction  

Event Description

A discrepant high hb1c result was obtained on a patient sample.The patient result was reported to the physician who questioned the result.The patient sample was rerun and a lower result was obtained concordant with physician expectations.A corrected result was issued.Patient treatment was not altered or prescribed on the basis of the discrepant high hb1c result.There was no report of adverse health consequences as a result of the discrepant high high hb1c result.

Manufacturer Narrative

Analysis of the instrument and instrument data indicate that the cause for the discrepant elevated hb1c result is unknown.However, user error may have contributed to the event.The hb1c instructions for use specimen collection and handling section cautions: sample can sit in sample cup on instrument for up to one hour.The laboratory reported that due to heavy workload the sample may have sat on the instrument for a long period of time before being picked up to be processed.The instrument is performing within specifications.No further evaluation of the device is required.

• Brand Name: DIMENSION(R) CLINICAL CHEMISTRY 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: 4745783
• MDR Text Key: 17216442
• Report Number: 2517506-2015-00139
• Device Sequence Number: 1
• Product Code: LCP
• 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 Facility
• Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date: 04/20/2015

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
• Device Operator: Medical Technologist
• Device Expiration Date: 05/05/2015
• Device Catalogue Number: DF105
• Device Lot Number: GC5125
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/15/2015
• Initial Date FDA Received: 05/04/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/10/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1