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

Catalog Number 08H67-01

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

All available patient information was included.Additional patient details are not available.An evaluation is in process.A final report will be submitted when the evaluation is complete.

Event Description

The customer observed a discrepant hemoglobin result while using the cell-dyn ruby analyzer.Sample id (b)(6) generated hemoglobin results of 10.1 and 7.42 g/dl.No impact to patient management was reported.

Manufacturer Narrative

The field service representative (fsr) inspected the cell- dyn ruby analyzer serial number (b)(4).And noted the rbc qc was out of range low and the platelets qc were out of range high.The hemoglobin (hgb) and hematocrit (hct) were not matching.An autoclean, voltage adjustment on the hgb flowcell, precision runs, calibrations, and mode to mode adjustments were all performed, and the patient comparisons appeared good.A review of the product historical data for trends and customer complaints did not identify any issues.Manufacturing documentation was reviewed, and also identified no issues.Additionally, labelling was reviewed and found to be adequate.Based on the investigation, no systemic issue or deficiency was identified for the cell-dyn ruby analyzer.

• Brand Name: CELL-DYN RUBY ANALYZER
• Type of Device: AUTOMATED HEMATOLOGY ANALYZER
• Manufacturer (Section D): ABBOTT DIAGNOSTICS DIVISION; 4551 great america parkway; santa clara CA 95054
• MDR Report Key: 8927530
• MDR Text Key: 184177218
• Report Number: 2919069-2019-00093
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00380740017170
• UDI-Public: 00380740017170
• Combination Product (y/n): N
• PMA/PMN Number: K061667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/06/2019

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 Catalogue Number: 08H67-01
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/30/2019
• Initial Date FDA Received: 08/23/2019
• Supplement Dates Manufacturer Received: 09/03/2019
• Supplement Dates FDA Received: 09/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1