MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION®; DIMENSION® RXL WITH HM

Model Number	DIMENSION® RXL WITH HM
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted the siemens customer care center (ccc) about a discordant falsely depressed hcg patient result obtained on the dimension rxl hm system.A siemens technical application specialist (tas) provided on-site support on 01-aug-2018 and verified calibration and controls with approved results.Siemens headquarters support center (hsc) reviewed the instrument data logs and the information provided.Hsc review of data from (b)(6) 2018 and (b)(6) 2018 shows a need to clean windows as the air blanks are high though (b)(6) 2018 looks better than (b)(6) 2018.There was some chrome imprecision on (b)(6) 2018, but it was resolved after the reagent 2 (r2) tip change in the (b)(6) 2018 data.The calibration data on (b)(6) 2018 shows some likely imprecision in the sample mix.Based on the filter data review, the event is consistent with a sample delivery issue which is consistent with the removal of the sample before the test sampled or a specimen integrity issue.The cause is unknown.The device is performing within specifications.No further evaluation of the device is required.
Event or Problem Description
A discordant falsely depressed human chorionic gonadotropin (hcg) result was obtained on a patient sample on the dimension rxl hm system.The result was reported to the physician who questioned the result.The same sample was reprocessed on the same system and a higher result was obtained.A corrected report was issued.There are no known reports of patient intervention or adverse health consequences due to the discordant falsely depressed human chorionic gonadotropin (hcg) result.

• Brand Name: DIMENSION®
• Common Device Name: DIMENSION® RXL WITH HM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• MDR Report Key: 7802639
• Report Number: 2517506-2018-00473
• Device Sequence Number: 2508066
• Product Code: JJE
• UDI-Device Identifier: 00842768013850
• UDI-Public: 00842768013850
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K112999
• 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
• Report Date (Section B): 08/21/2018

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 Model Number: DIMENSION® RXL WITH HM
• Device Catalogue Number: SMN 10461511
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2018
• Initial Report FDA Received Date: 08/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1