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

Catalog Number	DF105A SMN10483822
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mdr 2517506-2018-00395 was filed for the same event.The customer contacted the siemens customer care center (ccc) for the discordant, hb1c results obtained on the dimension exl system.Siemens headquarters support (hsc) reviewed the information provided and the cause of event was identified as use error for entering incorrect scaler units for hb1c lot ga8299.Hsc concluded that no product non-conformance was identified with the reagent and no product nonconformance was identified with the instrument.The incorrect scaler units were entered during a calibration which occurred on (b)(6) 2018.During the time period of (b)(6) 2018 to(b)(6) 2018, 859 patient results were reported.It is unknown if physicians questioned the results.There were 15 random patient samples processed again after recalibration on the same instrument at a later date, using the correct scaler % units and on an alternate instrument at an alternate facility obtaining the correct results.Based on the repeated results a letter was issued to all ordering physicians informing them of the possible bias.All 859 patient results were appended with the following statement to identify the bias: hba1c reported <7.0% negative bias of 0.3 -0.6%; hba1c reported between 7.0 - 9.0% no significant difference; hba1c reported > 9.0% positive bias of 0.5%.The device is operating within specifications.No further investigation is required.
Event or Problem Description
Discordant hemoglobin a1c (hb1c) results were obtained on multiple patient samples on the dimension exl instrument due to use error.The customer entered the scalers for hb1c using mmol/l units instead of % units.An incorrect calibration occurred prior to the event date and the customer did not detect the error until recalibration of hb1c assay on (b)(6) 2018.The original results with mmol/l scaler units were reported to the physician.A letter was issued to all ordering physicians informing of the possible bias in results.A random subset of patient samples were processed again after recalibration on the same instrument at a later date, using the correct scaler % units and on an alternate instrument at an alternate facility obtaining the correct results.There was no known impact on patient treatment or care and no alleged patient harm due to the discordant hb1c results.

• 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: 7642863
• Report Number: 2517506-2018-00394
• Device Sequence Number: 1898971
• Product Code: LCP
• UDI-Device Identifier: 00842768032615
• UDI-Public: 00842768032615
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 06/27/2018

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: 10/26/2018
• Device Catalogue Number: DF105A SMN10483822
• Device Lot Number: GA8299
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/31/2018
• Initial Report FDA Received Date: 06/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1