MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC ADVIA AUTOSLIDE SYSTEM

Model Number	ADVIA AUTOSLIDE SYSTEM
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc).A siemens customer service engineer (cse) was dispatched to the customer's site.The customer suspected that the patient sample, that was ordered for testing, after the affected sample was on the affected slide.The cse inspected the instrument with the customer and siemens is investigating the issue.
Event or Problem Description
A customer reported that a panel of complete blood count (cbc) results obtained on a patient sample, from a slide produced by an advia autoslide system, did not correlate with the results obtained on an advia 2120i hematology system with dual aspirate autosampler.The customer reported that the results from the advia 2120i hematology system with dual aspirate autosampler were expected.The results obtained from the slide produced on the advia autoslide system were reported to the physician(s) and questioned.The customer indicated that the slide produced by the advia autoslide system was labeled with the corrected sample id, but contained another patient's blood sample.The customer manually created a slide using the affected patient sample and stained it using a hematek instrument; the results obtained from the manually produced slide confirmed the results obtained on the advia 2120i hematology system with dual aspirate autosampler.There are no known reports of patient intervention or adverse health consequences due to the incorrect patient's blood sample produced on another patient's slide.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2432235-2018-00337 on (b)(6) 2018.Additional information (b)(6) 2018): siemens reviewed the information provided by the customer and the cause of the incorrect blood sample on the patient slide could not be determined.The customer reported that the sample was also repeated on an alternate advia 2120i hematology system, but did not provide the results.The customer indicated that the results obtained on the alternate advia 2120i hematology system were similar to the results obtained on the initial advia 2120i hematology system with dual aspirate autosampler.The result code and conclusion code of section were updated to reflect the additional information.The customer provided the complete blood count obtained on the patient sample on the initial advia 2120i hematology system with dual aspirate autosampler.Section was updated to reflect the additional information.The customer clarified that they did not report this event to the fda.Section was updated to reflect this information.

• Brand Name: ADVIA AUTOSLIDE SYSTEM
• Common Device Name: ADVIA AUTOSLIDE SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 511 benedict ave; tarrytown NY 10591
• MDR Report Key: 7866469
• Report Number: 2432235-2018-00337
• Device Sequence Number: 13938046
• Product Code: KPA
• UDI-Device Identifier: 00630414560595
• UDI-Public: 00630414560595
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K051693
• 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,Followup
• Report Date (Section B): 10/10/2018

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: ADVIA AUTOSLIDE SYSTEM
• Device Catalogue Number: 10282177
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/24/2018
• Supplement Date Received by Manufacturer: 09/14/2018
• Initial Report FDA Received Date: 09/11/2018
• Supplement Report FDA Received Date: 10/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1