MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION®; DIMENSION® HCG HUMAN CHORIONIC GONADOTROPIN FLEX® REAGENT CARTRIDGE

Catalog Number	RF430 SMN 10444913
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mdr 2517506-2018-00631 was also filed for the same event.The customer contacted the siemens healthcare diagnostics customer care center concerning discordant low hcg results reported on two patient samples.The discrepant low results were accompanied with a high absorbance ("high a") error message on the dimension exl instrument printout but were reported through the laboratory information system (lis) without the error message.Siemens headquarters support center (hsc) reviewed the information provided and determined that the customer reported flagged results which should not have been reported.The customer reviewed the instrument print-outs for these patients and noted the high "a" error message on the printout.For the high a error the dimension exl operator's guide states: "urine drugs of abuse assays should be centrifuged and rerun.For other assays, manually dilute the sample and rerun the assay.Make the smallest dilution possible to bring the result down into the assay range.Enter the dilution factor as a whole number on the enter sample data screen and the instrument will multiply the result by this factor." the customer's auto-dilution feature for hcg was turned off.The customer has re-enabled the feature and has not had the issue since.The customer stated they were going to work with lis provider to address translation of result flags and suppression of the numerical result.The dimension exl instrument was performing as intended for high hcg samples.No product or system non-conformance was identified.The cause of the event was use error.The device is performing within specifications.No further evaluation is required.
Event or Problem Description
Discordant depressed human chorionic gonadotropin (hcg) results were obtained on patient samples on the dimension exl with lm system.The results were reported to the physician(s) who questioned the results.The same samples were reprocessed the same day at an alternate facility and higher results were obtained.Corrected reports were issued.No treatment was provided to the patients on the basis of the reported discordant hcg results.There are no known reports of patient intervention or adverse health consequences due to the discordant hcg results.

• Brand Name: DIMENSION®
• Common Device Name: DIMENSION® HCG HUMAN CHORIONIC GONADOTROPIN FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• MDR Report Key: 8054859
• Report Number: 2517506-2018-00630
• Device Sequence Number: 11243765
• Product Code: DHA
• UDI-Device Identifier: 00842768013850
• UDI-Public: 00842768013850
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K970387
• 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): 11/09/2018

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: 05/16/2019
• Device Catalogue Number: RF430 SMN 10444913
• Device Lot Number: FA9136
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2018
• Initial Report FDA Received Date: 11/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1