MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION®; DIMENSION® TBI TOTAL BILIRUBIN FLEX® REAGENT CARTRIDGE

Catalog Number	DF167 SMN10444957
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc) for the falsely depressed total bilirubin (tbi) result.The customer stated that the 12:13 pm patient sample was laid down next to the patient under the phototherapy light for some time and a physician questioned whether it may have degraded the tbi in the sample.Siemens headquarters support center (hsc) has reviewed the information provided and concludes that this event is not a reagent lot or assay issue.Quality control was within range at the time of the event.The dimension tbi reagent cartridge instructions for use states the following in the specimen collection and handling section: "bilirubin is extremely photosensitive.Care should be taken to protect sample from both daylight and fluorescent light to avoid photodegradation." the cause of the discordant tbi result is unknown.No product nonconformance was identified.The device is performing according to specifications.No further evaluation of the device is required.
Event or Problem Description
A discordant depressed total bilirubin (tbi) result was obtained on a neonate patient sample on the dimension exl system.The result was reported to the physician who questioned the result.A new sample was drawn and processed and a higher result was obtained.There are no known reports of patient intervention or adverse health consequences due to the discordant tbi result.No corrected reported was issued.

• Brand Name: DIMENSION®
• Common Device Name: DIMENSION® TBI TOTAL BILIRUBIN FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 500 gbc drive; p.o. bos 6101; newark DE 19714 6101
• MDR Report Key: 8317404
• Report Number: 2517506-2019-00058
• Device Sequence Number: 19098740
• Product Code: CIG
• UDI-Device Identifier: 00842768020544
• UDI-Public: 00842768020544
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K060628
• 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): 02/07/2019

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: 08/21/2019
• Device Catalogue Number: DF167 SMN10444957
• Device Lot Number: EB9233
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2019
• Initial Report FDA Received Date: 02/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1