MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC SYVA EMIT 2000; SYVA® EMIT 2000 VANCOMYCIN ASSAY

Model Number	SYVA® EMIT 2000 VANCOMYCIN ASSAY
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mdr 2517506-2020-00189 was filed for the same event.(same patient).Beckman coulter, the distributor of the siemens healthcare diagnostics emit 2000 vancomycin assay, contacted siemens and reported that an elevated vancomycin result obtained on the beckman au5800 system was questioned as discordant by their customer.Siemens is investigating the event.
Event or Problem Description
An elevated emit 200 vancomycin result, considered by the physician to be discordant, was obtained on a patient sample on a beckman au5800 system.The result was reported to the physician(s) who questioned the result.The same sample was reprocessed on the same system and elevated results were obtained and reported.There are no known reports of patient intervention or adverse health consequences due to the vancomycin results which were regarded as discordant.
Additional Manufacturer Narrative
New information (22-jul-2020): siemens healthcare diagnostics headquarters support center (hsc) concluded their investigation of the falsely elevated vancomycin result.Hsc had requested patient samples to be returned to siemens for testing, but the customer no longer had the samples available.Siemens evaluated the manufacturing batch and quality control records for the vancomycin lot and all data was within specifications.No similar events had been seen in an evaluation of complaint records from 01-aug-2019 to 14-jul-2020 to rule out any systemic product problem.The event is isolated to this one patient.No instrument issues were reported.Quality control was within range and no issues were noted with other patient samples indicating that the instrument and reagent were performing acceptably.Based on the results of the investigation no potential product issue has been identified.The cause of the event is unknown.The device is performing within specifications.No further evaluation is required.Section h6 has been updated to reflect the hsc investigation.Original mdr 2517506-2020-00188 was filed 25-jun-2020.Mdr 2517506-2020-00189 was filed for the same event.Mdr supplement 2517506-2020-00189 supplement 1 was filed for the same event.

• Brand Name: SYVA EMIT 2000
• Common Device Name: SYVA® EMIT 2000 VANCOMYCIN ASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 500 gbc drive; po box 6101; newark, de
• MDR Report Key: 10194313
• Report Number: 2517506-2020-00188
• Device Sequence Number: 887125
• Product Code: LEH
• UDI-Device Identifier: 00842768023323
• UDI-Public: 00842768023323
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K020692
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2020

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: 08/21/2020
• Device Model Number: SYVA® EMIT 2000 VANCOMYCIN ASSAY
• Device Catalogue Number: SMN 10445338
• Device Lot Number: M5
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/01/2020
• Supplement Date Received by Manufacturer: 07/22/2020
• Initial Report FDA Received Date: 06/25/2020
• Supplement Report FDA Received Date: 07/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR