MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION®; DIMENSION® A1C HEMOGLOBIN A1C ASSAY

Model Number	10720883
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mdr 2517506-2020-00070 was filed 21-feb-2020 for the same event.The customer contacted the siemens customer care center (ccc) and reported that a falsely elevated hemoglobin a1c (a1c) patient result was obtained on a dimension exl 200 instrument.Siemens healthcare diagnostics headquarters support center (hsc) concluded their investigation of the discordant falsely elevated hemoglobin a1 result.Hsc evaluated the information provided.No product problem was identified.The event was resolved by recalibration of the a1c assay.The customer reports that the values recovered are now as expected and the analyzer is performing as expected in normal use.The instrument is operational.The cause of this event is unknown.The device is performing within specifications.No further evaluation is required.
Event or Problem Description
A falsely elevated hemoglobin a1c (a1c) result was obtained on a patient whole blood sample on a dimension exl with lm instrument.The result was reported to the physician(s).The same sample was repeated on the same instrument after recalibration of the assay and dilution of the sample.A lower result was obtained and a corrected result was issued.The account stated that a cardiac catheterization was delayed.There are no known reports adverse health consequences due to the falsely elevated aic result or the delay.

• Brand Name: DIMENSION®
• Common Device Name: DIMENSION® A1C HEMOGLOBIN A1C ASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 500 gbc drive; po box 6101; newark, de
• MDR Report Key: 9774733
• Report Number: 2517506-2020-00069
• Device Sequence Number: 11386546
• Product Code: PDJ
• UDI-Device Identifier: 00630414006659
• UDI-Public: 00630414006659
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173909
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/02/2020

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: 04/15/2020
• Device Model Number: 10720883
• Device Catalogue Number: DF105B SMN 10720883
• Device Lot Number: GD0106
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 03/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR