MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS DIVISION CELL-DYN 1800 ANALYZER; AUTOMATED HEMATOLOGY ANALYZER

Catalog Number	07H77-01
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 the cd1800 analyzer generated an elevated wbc result of 62,300/ul.The sample was repeated on another cd1800 in the lab and a result of 9,900/ul was generated.The customer performed an autoclean on the original analyzer and repeated the sample and a result of 10,000/ul was generated.There was no report of impact to patient management.
Additional Manufacturer Narrative
A field service representative (fsr) visitied the account and found that the wbc transducer was damaged.The fsr replaced the transducer to resolve the issue.Customer complaint data was reviewed and no adverse trends were identified.The cell-dyn 1800 system operations manual was reviewed and was found to adequately address the issue.The investigation did not identify a product deficiency.

• Brand Name: CELL-DYN 1800 ANALYZER
• Common Device Name: AUTOMATED HEMATOLOGY ANALYZER
• Manufacturer (Section D): ABBOTT DIAGNOSTICS DIVISION; 4551 great america parkway; santa clara CA 95054
• MDR Report Key: 6316167
• Report Number: 2919069-2017-00009
• Device Sequence Number: 1199825
• Product Code: GKZ
• UDI-Device Identifier: 00380740071141
• UDI-Public: 00380740071141
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K030513
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2017

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: 07H77-01
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/18/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/09/2017
• Supplement Report FDA Received Date: 03/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1