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

Model Number	08H00-03
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow up report will be submitted when the evaluation is completed.
Event or Problem Description
The account generated false elevated hemoglobin of 19 g/dl with the cell-dyn sapphire on patient sample that generated hemoglobin of 6 g/dl on cell-dyn ruby.The account accepted the cell-dyn ruby results to be correct.No specific patient information was provided.No impact to patient management was reported.
Additional Manufacturer Narrative
A review was performed for any trends and all customer complaints received for this issue.The review of this data did not identify any adverse trends or abnormal complaint activity.No data, other than the comments in the complaint text, were provided.No customer returns were available for analysis.A review of the product labeling concluded that the issue is sufficiently addressed.The complaint issue was resolved by cleaning the hemoglobin tank, optical line, dilution wells, impedance count opening and special protocol primes on the cell-dyn sapphire.No product deficiency was identified.

• Brand Name: CELL-DYN SAPPHIRE ANALYZER
• Common Device Name: AUTOMATED HEMATOLOGY ANALYZER
• Manufacturer (Section D): ABBOTT DIAGNOSTICS DIVISION; 4551 great america parkway; santa clara CA 95054
• MDR Report Key: 10160999
• Report Number: 2919069-2020-00024
• Device Sequence Number: 2911328
• Product Code: GKZ
• UDI-Device Identifier: 00380740016623
• UDI-Public: 00380740016623
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K051215
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2020

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 Model Number: 08H00-03
• Device Catalogue Number: 08H00-03
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/22/2020
• Supplement Date Received by Manufacturer: 07/08/2020
• Initial Report FDA Received Date: 06/17/2020
• Supplement Report FDA Received Date: 08/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1