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U.S. Department of Health and Human Services

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

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ABBOTT DIAGNOSTICS DIVISION CELL-DYN SAPPHIRE ANALYZER; AUTOMATED HEMATOLOGY ANALYZER Back to Search Results
Model Number 08H00-01
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/20/2019
Event Type  malfunction  
Manufacturer Narrative
All available patient information has been included.No additional patient details are available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
 
Event Description
The customer reported that the results on the lis did not match those on the cell dyn sapphire screen.No impact to patient management was reported.
 
Manufacturer Narrative
An investigation was performed for the customer issue and included a review of complaint text, a review of trending data and a review of product labeling.A review was performed for any trends and all customer complaints received for this issue.The review of this data did not identify any trends.Return sample analysis is not applicable because returns are not available.Labeling was reviewed and found to be adequate.Based on all available information and abbott diagnostics' complaint investigation a product deficiency was not identified.
 
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Brand Name
CELL-DYN SAPPHIRE ANALYZER
Type of Device
AUTOMATED HEMATOLOGY ANALYZER
Manufacturer (Section D)
ABBOTT DIAGNOSTICS DIVISION
4551 great america parkway
santa clara CA 95054
MDR Report Key9432913
MDR Text Key190383887
Report Number2919069-2019-00116
Device Sequence Number1
Product Code GKZ
UDI-Device Identifier00380740016616
UDI-Public00380740016616
Combination Product (y/n)N
PMA/PMN Number
K051215
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 03/25/2020
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
Device Operator Health Professional
Device Model Number08H00-01
Device Catalogue Number08H00-01
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 11/20/2019
Initial Date FDA Received12/06/2019
Supplement Dates Manufacturer Received03/04/2020
Supplement Dates FDA Received03/25/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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