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

Catalog Number	DF105A SMN 10483822
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/08/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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®
• Common Device Name: 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
• Report Number: 2517506-2019-00174
• Device Sequence Number: 1638969
• Product Code: LCP
• UDI-Device Identifier: 00842768032615
• UDI-Public: 00842768032615
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K102510
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2019

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: 07/09/2019
• Device Catalogue Number: DF105A SMN 10483822
• Device Lot Number: GC9190
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/08/2019
• Supplement Date Received by Manufacturer: 05/06/2019
• Initial Report FDA Received Date: 04/29/2019
• Supplement Report FDA Received Date: 05/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1