MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS DIVISION CELL-DYN RUBY ANALYZER; AUTOMATED HEMATOLOGY ANALYZER

Catalog Number	08H67-03
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot/serial number was manufactured prior to udi compliance date; therefore, only a di is provided an evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer stated that discrepant platelet results were generated by the celldyn ruby analyzer.Results of 18,600/ul and 20,100/ul were generated.The sample was sent to another laboratory and results of 98,100/ul (plto) and 151,000/ul (plti) were generated.There was no report of impact to patient management.
Additional Manufacturer Narrative
Customer stated that discrepant plt results were generated by the cell-dyn ruby.The separation between the red blood cell and plt was questionable.Review of data found microcytic rbc interfered with plt.Customer complaint data was reviewed and no adverse trends related to the customer issue were identified.Based on the investigation, the complaint incidents were sample-specific issues involving interfering substances and conditions, in this case, microcytic rbcs.The cell-dyn ruby operation manual was reviewed and was found to adequately address the issue.A malfunction was identified as the product failed to meet performance specifications or otherwise perform as intended at the customer site.However no product deficiency was identified.

• Brand Name: CELL-DYN RUBY ANALYZER
• Common Device Name: AUTOMATED HEMATOLOGY ANALYZER
• Manufacturer (Section D): ABBOTT DIAGNOSTICS DIVISION; 4551 great america parkway; santa clara CA 95054
• MDR Report Key: 6523360
• Report Number: 2919069-2017-00080
• Device Sequence Number: 18835346
• Product Code: GKZ
• UDI-Device Identifier: 00380740099916
• UDI-Public: 00380740099916
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K061667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2017

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 Catalogue Number: 08H67-03
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/07/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/26/2017
• Supplement Report FDA Received Date: 06/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1