MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION®; DIMENSION® HB1C HEMOGLOBIN A1C KIT

Catalog Number DF105A SMN 10483822

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/08/2019

Event Type  malfunction  

Manufacturer Narrative

Siemens healthcare diagnostics headquarters support center (hsc) concluded their investigation of the discordant, falsely elevated hemoglobin a1c (hb1c) results.The siemens hb1c assay is cleared for monitoring diabetic therapy and not for use in the diagnosis of diabetes.All hb1c assay results processed by the dimension exl 200 instrument were within the instructions for use reference range for adults without suspected diabetes.The customer using the hb1c assay beyond what it is cleared for or beyond the hb1c assay intended use is not supported by siemens.The issue was caused by customer user error.No product non-conformance was identified.The device is performing within specifications.No further evaluation is required.

Event Description

Discordant, falsely elevated hemoglobin a1c (hb1c) results were obtained on patient samples on the dimension exl 200 instrument on (b)(6) 2019.The results were reported to the physician (s) and were questioned.The same samples were reprocessed using an alternate methodology on a non-siemens instrument on the same date and lower hemoglobin a1c results were obtained.On (b)(6) 2019, siemens was informed that the physicians (s) regarded the dimension hb1c results as high and started treatment for pre-diabetes.The type of treatment was not specified.There was no alleged patient harm due to the discordant elevated hb1c results or due to the treatment.

Manufacturer Narrative

Original mdr 2517506-2019-00174 was filed 29-apr-2019.Corrected information (06-may-2019): siemens was informed that the correct date of testing for sample id 1017275409 for hb1c is 18-mar-2019.

• Brand Name: DIMENSION®
• Type of Device: DIMENSION® HB1C HEMOGLOBIN A1C KIT
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• MDR Report Key: 8561220
• MDR Text Key: 151134237
• Report Number: 2517506-2019-00174
• Device Sequence Number: 1
• Product Code: LCP
• UDI-Device Identifier: 00842768032615
• UDI-Public: 00842768032615
• Combination Product (y/n): N
• PMA/PMN Number: K102510
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 05/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/09/2019
• Device Catalogue Number: DF105A SMN 10483822
• Device Lot Number: GC9190
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1